Manager, Clinical Resume Sample

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Hailie Olson
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Work Experience


Manager, Clinical Services
07/2016 - PRESENT
Dallas, TX
  • Collaborate with the Therapeutic Area(s) management (faculty and Clinical Operations management), Business Development, cross-functional management, and the proposal project leader in the development of scope of work, associated budget and timelines for new business proposals (commercial and government) as required
  • Represent Clinical Operations in sponsor meetings, including new business, operational meetings and sponsor audits
  • Participate in scientific meetings as appropriate
  • Provide disease-state based preclinical input for animal study models and targeted patients, and provide the scientific link to engineering teams for early-stage R&D programs
  • Maintain open 2-way communications with investigators on patient selection, data analyses, presentations and publications
  • Managing key stake holder expectations regarding P & L operations
  • Lead the implementation of strategic plans in line with the organizations vision mission and goals
  • Problem Solving /Decision making that affect multiple functions that support the overall efficiency of P & L
  • Drives implementation of internal requirements to external partners, follows-up on testing and documentation to support clinical pack & label operations following regulatory and GMP requirements
Manager, Clinical Quality
03/2009 - 01/2016
Phoenix, AZ
  • Initiates and facilitates communication between cross functional teams
  • Communicates effectively across the organization providing appropriate content for various levels
  • Focuses on new and evolving business needs taking action to implement or address issues
  • Driving lean principals and collaborates on the strategy for demand versus supply and execution to improve CSC compound performance and On-Time-Delivery (OTD)
  • Experience managing Clinical trials required
  • Direct oversight of Pathology support services (e.g., specimen accessioning, clerical) to assure adequate and competent staffing for timely pathology services
  • Directly supervises the Laboratory Assistants. Directly manages specimen receiving, processing and ransportation between AHS sites (FH/JGPP and HGH – K, HCP and HGH locations); supervision and oversight of the morgue attendant (2) schedule, dutiesand morgue functions
  • Quick learner; ability to come up to speed quickly on Edwards’ products and services
Senior Manager, Clinical Affairs
05/2005 - 01/2009
Los Angeles, CA
  • Develops Quality Plans for studies and CRO’s. Ensures execution of the Quality Plans. Manages contract resources in the execution of the Quality Plans
  • Partners with Clinical Operations in the qualification of CRO’s
  • Supervision of Staff Activities; Serve as supervisor for assigned Clinical Operations staff within therapeutic area(s) and assess assigned staff on work assignments, utilization and productivity
  • Develop written performance standards for Clinical Operations personnel
  • Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues
  • Conduct performance evaluations for assigned staff
  • Work with internal and external training resources as required; ensure that all staff assigned are current with their required training (non-study specific) including SOPs, ICH/GCP, and field-based training

Education


University of Southern Nevada
1999 - 2004
Bachelor's Degree in Nursing

Professional Skills


  • Strong skills in GCP, quality and/or clinical development. Experience with managing Authority inspections, desirable. Auditing Experience desirable
  • Advanced problem solving skills in a team environment. Excellent influencing skills
  • Outstanding customer relations skills with demonstrated accomplishments working with internal and external stakeholders
  • Proven Problem Resolution Skills including identification, tracking, escalation and resolution
  • Excellent written and verbal communication and decision making skills
  • Excellent analytical and problem solving skills with an eye for detail
  • Proven successful project management leadership skills with ability to meet deadlines on multiple projects

How to write Manager, Clinical Resume

Manager, Clinical role is responsible for clinical, interpersonal, organizational, leadership, activities, drive, medical, analytical, organization, sourcing.
To write great resume for manager, clinical job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Manager, Clinical Resume

The section contact information is important in your manager, clinical resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Manager, Clinical Resume

The section work experience is an essential part of your manager, clinical resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous manager, clinical responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular manager, clinical position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Manager, Clinical resume experience can include:

  • Proficient consulting report writing skills and ability to present findings and recommendations concisely and effectively
  • Strong communication, organization, planning, analytical, problem solving, and people management skills
  • Able to effectively guide and instruct other imaging specialists in clinical settings on effective imaging equipment operation
  • Excellent written and verbal communication, influencing and persuasion skills
  • Experience working effectively in a diverse, global environment
  • Excellent communication skills including an ability to influence at all levels of the organization

Education on a Manager, Clinical Resume

Make sure to make education a priority on your manager, clinical resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your manager, clinical experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Manager, Clinical Resume

When listing skills on your manager, clinical resume, remember always to be honest about your level of ability. Include the Skills section after experience. Present the most important skills in your resume, there's a list of typical manager, clinical skills:

  • Excellent verbal and written communication skills; excellent interpersonal and collaboration skills
  • Excellent written, oral communication skills and presentation skills
  • Excellent verbal and written communication skills, strong analytical and organizational abilities
  • Experience as a Clinical Project Lead or Clinical Research Associate with demonstrated leadership skills
  • Excellent verbal and written communication skills. Ability to utilize tact and diplomacy in dealing with people
  • Excellent leadership, communication, and influencing skills

List of Typical Experience For a Manager, Clinical Resume

1

Experience For Manager, Clinical Services Resume

  • Effectively functions in a Matrix reporting model – Interfaces and collaborates with leaders and colleagues across the Enterprise
  • Communicate effectively with multidisciplinary teams to support critical path activities
  • Three or more years’ experience working with clients in a clinical setting
  • Experience developing and maintaining department Standard Operational Procedures (SOPs)
  • Good understanding of Clinical Development
2

Experience For Manager, Clinical Quality Resume

  • Plans and makes decisions by considering impact from all relevant perspectives; able to verbalize decisions in a thorough and effective manner
  • Experience in submission of IDEs, Post Marketing Applications (PMAs) to the Food and Drug Administration (FDA) agency, as well as meetings with FDA
  • Experience Working in a Heavily Regulated Environment Desired
  • Experience working in clinical research is required
  • Experience in conducting clinical audits (Clinical Investigator Sites, Clinical Vendors, Trial Master Files, Clinical Study Reports, etc.,) is required
  • Experience working in a R&D/Clinical Trials/Clinical QA environment is required
  • Manage team members and/or experienced clinical development professionals and/or oversee the work of assigned team within own function
  • Oversee system validation activities, including authoring technical requirements, report specifications, test plans and other documentation
  • Understanding of clinical outsourcing processes supporting R&D in the U.S and abroad
3

Experience For Manager, Clinical Trials Resume

  • Ensuring coordination with project manager around documenting and communicating all process requirements and next steps to team members
  • Supporting and Administrating Clinical systems
  • Managing complex high-impact IT projects from start to finish
  • Analyzing process needed corrections and future enhancements
  • Managing and communicate the status of study progress and activities
  • Working knowledge of CRM funnel and account management processes
  • Mentoring pharmacy students during their clinical internship and serves as a preceptor for the state of Texas and other affiliated pharmacy schools
4

Experience For Senior Manager, Clinical Affairs Resume

  • Understanding of clinical research terminology, business practice, process, timeline and key budget drivers
  • Outstanding financial acumen blended with business partnership
  • Manage resources to ensure all project teams are adequately supported, including forecasting, hiring and training
  • Keeps current with industry trends in oncology nursing and practice management for the purpose of enhancing existing programs and developing new ones
  • Provide development opportunities for assigned staff including coaching, mentoring and performance management
  • Functional Group/ Therapeutic Area(s) Support and Strategic Planning; Coordinate the standardization and maintenance of status reports and other information sources
  • Work with project leadership to facilitate cross-functional team and multiple business- partner communication for proactive study-wide problem solving regarding study progress and trial issues
  • New Business Development; Collaborate with the Therapeutic Area(s) management (faculty and Clinical Operations management), Business Development, cross-functional management, and the proposal project leader in the development of scope of work, associated budget and timelines for new business proposals (commercial and government) as required
  • Monitoring Activities; Perform activities of Lead CRAs (Senior CRA and other monitoring staff) on a temporary basis as needed to move project deliverables and timelines forward
5

Experience For Manager Clinical Resume

  • Experience in pharmaceutical clinical research including organizing and coordinating clinical trials
  • Evaluates effectiveness of training programs for new and existing colleagues
  • Provide managerial support to Outsourcing Team and guidance to improve streamlining Outsourcing functionality and processes
  • Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Director
  • Designs, develops, facilitates, and delivers clinical and corporate training programs across multiple users and locations, for both new and existing staff
6

Experience For Manager, Clinical Affairs Resume

  • Functions independently and autonomously in executing a wide variety of training initiatives
  • Utilizes creative and adaptive teaching techniques to accommodate adult learning needs
  • Responsible for reporting and documenting procedures in compliance with FDA regulations
  • Provides new employee orientation/training/monitoring
  • Prepares activity, resource and progress reports regarding the clinical programming group for upper management review
  • Planning and Goal Setting
7

Experience For Senior Manager, Clinical Development Resume

  • Responsible for ensuring protocol compliance by staff and providing recommendations for corrective action when necessary
  • Develops corrective action plans (CAPAs) as needed and ensure adherence to them through training and monitoring
  • Provides ongoing mentoring and guidance to CRA’s/CTAs as assigned
  • Assists with timelines of investigational product manufacturing, labeling, release and management
  • Provides ongoing mentoring and guidance to CRA’s/CTAs
8

Experience For Manager, Clinical Ancillary Solutions Resume

  • Coordinate with reporting team / IT to ensure necessary operational and outcome reporting is developed
  • Develop handoff plan to clinical lead to ensure ongoing monitoring and adjustment of project scope
  • Ensures the proper management and training of all trial management, CRO staff and field clinical specialists working on Edwards’ research programs
  • Assist with ongoing outsourcing strategy review and development
  • Represents OPDC Clinical Outsourcing on various Provider Partnership Committees including Operational and Program-Level Governances as needed
  • IT Programming and Technical Trainingin Data Extraction & Modeling
9

Experience For Manager Clinical Systems Resume

  • Represent the Clinical Programming section in management, committee, and working group meetings
  • Other General Activities; Interview job candidates and make hiring recommendations for Clinical Operations positions
  • As an individual contributor, carries out complex or novel assignments requiring the development of new or improved techniques or procedures
  • Provides pre- and post-training support to participants as needed
  • Conducts needs assessments to identify system and work flow training needs
  • Maintain spending within budget constraints
  • Utilize rounding boards and staff huddles to support Organizational and CTO goals
  • Lead the preparation for external audits in collaboration with Research Quality Monitoring
  • In collaboration with CTO Leadership, develop, maintain and monitor staffing plan for assigned teams
10

Experience For Manager, Clinical Documentation Resume

  • Monitor time and effort tracking reports on a periodic basis and review with Portfolio Supervisor as needed
  • Collaborate with human resources to provide counseling or performance improvement of staff as needed
  • Manage and lead staff to develop collaborative working relationships within the department and with other departments as applicable
  • Attends all pertinent departmental COH and Working Group meetings
  • Develops quarterly and annual staffing plan in collaboration with CTO Leadership
  • Identifies and communicates opportunities for improved efficiency and/or cost saving within the department
  • Develops working relationships with study sponsors for future collaborations

List of Typical Skills For a Manager, Clinical Resume

1

Skills For Manager, Clinical Services Resume

  • Demonstrate effective managerial skills
  • Reporting and Analytics or related experience coupled with demonstrated leadership or supervisory/management experience
  • Excellent data analysis, reporting and analytics skills
  • Demonstrated consultation and relationship building skills
  • Prior clinical research experience within Medical Devices including PMA, IDE, 510k is a strong preference
  • Demonstrated successful completion of projects through planning and organizational skills
  • Proven ability to communicate and negotiate effectively with stakeholders at all levels across functional boundaries
  • Strong communication, presentation and interpersonal skills to be able to engage and manage expectations of senior management, particularly Finance and R&D Ops
  • Strong organizational, presentation, documentation, and interpersonal skills
2

Skills For Manager, Clinical Quality Resume

  • Strong medical and scientific writing skills with ability to author protocols, literature reviews and technical study documents
  • Good presentation, relationship management, and analytical skills
  • Highly organized with strong negotiation skills
  • Demonstrated ability to communicate effectively in a matrix management environment
  • Strong leadership/management skills required
  • Excellent Computer skills - Microsoft Office (Word, Excel, Access, PowerPoint), Adobe Acrobat Pro, Internet
3

Skills For Manager, Clinical Trials Resume

  • Excellent analytical and presentation skills to scientific and non-scientific audiences
  • Knowledge and demonstrated skills in excel
  • Good process development skills
  • Excellent organizational and technical database skills
  • Related experience managing or directing clinical teams including scheduling and prioritizing work
  • Experience with SAS statistical software is essential, including macro and reporting experience
4

Skills For Senior Manager, Clinical Affairs Resume

  • Financial budgeting and forecasting skills
  • Strong and influential leadership with a proven ability to lead a clinical team in the development of products for medical imaging
  • Prior clinical research experience within Medical Devices including PMA, IDE
  • Basic budgetary understanding and capability; able to effectively manage expenses
  • Experience in purchasing, sales, client services and/or equivalent combination of education and experience
  • Experience behavioral health experience or health-related field
5

Skills For Manager Clinical Resume

  • Knowledgeable of application programming skills and technologies
  • Proven ability to provide effective consultation and training
  • Can demonstrate experience in leadership within a matrix team environment
  • Strong leadership ability including experience leading, guiding, and mentoring other members of a team or project
  • Basic skills in organization
  • Risk and financial analysis skills and the ability to interpret and utilize key financial data
  • Proven experience in project management is required
6

Skills For Manager, Clinical Affairs Resume

  • Prior clinical research experience with class II or III medical devices
  • Effectively interact with and present to management, as well as to external audiences and inspectors
  • Collaborate effectively with all other Care1st departments
  • Written, verbal communication and presentation skills in small and large group settings
  • Excellence in interpersonal and written communication skills
  • Appropriate clinical skills
  • Knowledgeable in US and international medical device regulations, Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
  • Seven or more years’ experience as a Clinical Research Coordinator with 2 or more years supervisory experience
7

Skills For Senior Manager, Clinical Development Resume

  • Superb verbal and written communication and project management skills
  • Building and maintaining effective strategic working relationships with internal and external partners including to deliver on business needs
  • Understanding of Medical Equipment utilized in acute care setting, to include experience working with vendors and hospital administration
  • Gathering detailed business and functional requirements, ensuring requirements are clear and understood prior to initiation of work
  • Working knowledge and experience with MEDITECH and PatientKeeper encouraged but not required
  • Highly effective at initiating and leading cross functional teams by building internal and external relationships that create alignment
  • Experience in Data Science, statistics, predictive modeling, text mining, machine learning or similar advanced analytics capabilities
8

Skills For Manager, Clinical Ancillary Solutions Resume

  • Works within an extensive global network within the GSK Data Quality Community to ensure knowledge sharing and learning from the collective past experience
  • Work experience in the healthcare or clinical trial industry monitoring and managing clinical trials
  • Experience developing trial plans and extensive clinical research knowledge and a cross-functional understanding of clinical trial methodology
  • Experience in development Engineering(Manufacturing or Research & Development)
  • Experience of project managing operational aspects of a clinical study including timelines, budgets and resource plan Strict attention to detail
  • Experience with study start-up, timeline planning and management and financial management of clinical trials including vendor oversight required
  • Experience with data collection processes, data review and comfort with using technology including analytics tools
  • Experience in supporting healthcare clinical systems
  • Experience in acute care setting
9

Skills For Manager Clinical Systems Resume

  • Knowledge of or experience programming in SAS
  • PhD) or 8-10 years (MS) of experience in pharmaceutical development and applied statistics/statistical consulting required
  • Nursing experience required
  • Excellent ability to foster open communication and practice active listening to encourage a collaborative team environment
  • Demonstrates a solution oriented approach to problem solving and a “can do” attitude. Ability to travel up to 15% of time
  • Five years of experience in procurement, preferably in Scientific/Clinical procurement and sourcing of services
  • Project management / Program management: Demonstrated ability in leading complex projects to successful and on time completion
  • Experience of working in international matrix organizations across functions and cultures
  • Team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others
10

Skills For Manager, Clinical Documentation Resume

  • Strong understanding of financial and compliance standards
  • Displays independent thinking and good judgment
  • At least eight years of experience as a programmer working in a clinical or statistical capacity
  • RN-level clinical nursing experience
  • Management-level experience in a clinical setting
  • Adaptable and flexible, with the ability to handle ambiguity and changing priorities

List of Typical Responsibilities For a Manager, Clinical Resume

1

Responsibilities For Manager, Clinical Services Resume

  • Excellent oral communications and customer relations skills
  • Manage work intake and assignments, workload prioritization, effort estimation and resource allocation including annual budgeting
  • Demonstrate professional leadership and commitment in administration of company values
  • Previous experience working with CROs and other key clinical service providers
  • Contract management and negotiation experience (budget and business terms and conditions)
  • Supervises and directs the team's work flow to provide effective and timely information systems services to clients
  • Ensuring that decisions made by the Clinical Sub‐team have functional backing
2

Responsibilities For Manager, Clinical Quality Resume

  • Ensuring alignment between the Core Team, Clinical Sub‐team and Clinical Trial Team(s)
  • Working towards the achievement of defined project stage gates and milestones
  • Overseeing all clinical development activities in collaboration with the Clinical Sub‐Team and Clinical Trial Team(s)
  • Serve as a lead outsourcing representative on applicable cross-functional clinical study and study start up teams
  • Responsible for preparing detailed request for proposal documents in conjunction with internal customers
  • Responsible to determine the involvement of Finance, Legal, Tax, QA, Compliance etc. and other interfaces during all stages of contract management
  • Contributes to continuous process improvement initiatives. Participates in establishing departmental and cross-functional policies and procedures
  • Oversees study planning and timelines to ensure alignment with overall clinical development plan
3

Responsibilities For Manager, Clinical Trials Resume

  • Works with management to determine resourcing needs as required
  • Conduct monthly audits of nursing and clinic staff to ensure regular checks are performed on crash carts
  • Assesses/coaches and evaluates staff level of practice. Develop programs that foster business development to positively impact transitions of care
  • Coordinates the development, implementation and evaluation of policies and procedures designed to improve transitions of care
  • Coordinates the activities of staff with other DHCH personnel
  • Ensures documentation of patient referrals is complete and accurate in accordance with DHCH policies and procedures
  • Monitors compliance with Medicare guidelines related to admission eligibility
  • Acts as an advisor or thought partner by structuring undefined issues for resolution, researching issues, summarizing information and working with relevant stakeholders to provide vice president with the information needed to make sound decisions
4

Responsibilities For Senior Manager, Clinical Affairs Resume

  • Act as leader and champion to new ideas that contribute to clinical excellence
  • Manage and maintain effective partnerships with contracted suppliers and drive supplier compliance by ensuring that standardized contracting practices are applied and maintained across all relevant providers
  • Work closely with the Legal Department to determine vendor prioritization and assist with administrative preparation of contracts, specifically study requirements for specific contracts or work orders for review/negotiation by Legal Department
  • Ensure vendors of outsourced clinical trial activities meet Alkermes quality standards and expectations and adhere to applicable Corporate SOP’s, policies, guidelines, and regulations
  • Establish and standardize clinical contracting practices, systems, and tools, in conjunction with the Legal Department, to support clinical studies in order to meet company goals and objectives and ensure providers continue to meet outsourcing expectations
  • Develop, execute, and manage source plans by leading cross-functional teams to develop value enabling category sourcing strategies that maximize opportunity and mitigate supply risk
  • Initiate and lead sourcing initiatives, RFx bids and analysis, and supplier evaluation and selection. Create supplier balanced scorecards to continuously measure, calibrate, and improve supplier relationships and performance
  • Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide, XPT files)
  • Leads the vendor evaluation and selection process for assigned clinical development and Regulatory Affairs categories
5

Responsibilities For Manager Clinical Resume

  • Manages vendor relationships and issue resolution, supports the internal project teams in resolution of vendor performance issues
  • Recruit and retain top performers and provide leadership to CIS team members assigned to one or more applications or customer groups
  • Manage workload and provide updates on project progress and customer/application status to management
  • Perform or oversee administration of one or more systems and projects. Manage changes to system and interact with drug safety personnel to improve process and troubleshoot issues within the system
  • Experience in managing IT contractors and staff
  • Strong knowledge of technologies such as Veeva, Extedo, and/or off-the-shelf software products that support Regulatory business
6

Responsibilities For Manager, Clinical Affairs Resume

  • Keeps current with the latest technology and industry trends; regularly attends training in order to maintain technical expertise
  • Develop processes and tools such as author guidelines and process flows and support author training to ensure timely and quality procedure preparation
  • Ensure assigned systems and team meet service level agreements with end users, both internal and external
  • Manage procedures, forms and templates related to clinical trials to ensure quality and timeliness
  • Track metrics and prepare reports for management related to cycle times and quality
7

Responsibilities For Senior Manager, Clinical Development Resume

  • Support internal audits related to clinical processes and systems
  • Establishes and executes risk management plans when required
  • With input from therapeutic area medical directors, contributes to the development of study documents including protocols, informed consent forms, and study manuals
  • Business Analysis, Data Modeling, Information Architecture
  • Develops study budgets as required
8

Responsibilities For Manager, Clinical Ancillary Solutions Resume

  • Oversees setup and management of CTMS and the TMF as assigned
  • Is responsible for the delivery of CPMO’s systems projects
  • Excellent verbal and written communication skills. Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills
  • Able to proactively identify and address areas of inefficiency and provide creative, successful solutions. Holds self and others accountable for adherence to high work and ethical standards
  • Flexible; adapts work style in order to meet department and company needs
9

Responsibilities For Manager Clinical Systems Resume

  • Able to deal with broad, new issues with limited guidance or direction
  • Develop solutions based on limited information and oversight
  • Serve as the primary medical writer for formulary dossiers for oncology/hematology products, including dossiers following the Academy of Managed Care Pharmacy (AMCP) Format, WellPoint Format, and global reimbursement dossiers, among others (in MS Word)
  • Serve as the primary medical writer for peer-reviewed publications including manuscripts and conference abstracts and posters (authorship opportunities exist, but cannot be guaranteed), and white papers
  • Coach staff on management of their departmental personnel including planning, assigning and directing work, addressing complaints and resolving problems
  • In collaboration with medical director for study, creates study plans and study specific working practices
  • Management responsibilities include professional development, performance appraisals and employee counseling to direct reports
  • Analyze staffing requirements and responsibilities related to business needs and forecasts
10

Responsibilities For Manager, Clinical Documentation Resume

  • Develop content for clinical and scientific presentations (in MS PowerPoint) in oncology
  • Establishes study team contacts, roles, responsibilities, and objectives
  • Develops study execution plans and risk management plans
  • Maintenance of Sites, Subjects and Data
  • Current RN License or other advanced medical license is required
  • Work cross-functionally with team members, SME’s, and other departments to achieve program goals on time and on budget and plan future business needs
  • Negotiate the terms, conditions, performance requirements and legal obligations of vendor contracts so as to derive maximum benefit and protection of corporate interests while minimizing risk and cost
  • Monitor investigations for timely submissions and ensure appropriate corrective action and close out
  • Directs the efforts of the Clinical Services Teams, Medical Specialist and Clinical Process Optimization Team to accomplish key business objectives and provide solutions to customers through actionable approaches to managing daily activities

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