Clinical Operations Resume Sample

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Estefania Ryan
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Work Experience


Director of Clinical Operations
05/2018 - PRESENT
Los Angeles, CA
  • Perform routine and special reporting pulls for all levels of management
  • Maintain SQL library for team and hold training with analyst when needed
  • Utilize SQL, Excel to launch theoretical claim queries into the system
  • Review data returned in the query for summary of results
  • Experience in Coordination of Clinical Trials – Preferably relevant working experience as an
  • Liaison between clinic leadership, provider, and requisite division personnel
  • Negotiate for clinic space with appropriate leadership
  • Serve as a liaison and value-added resource between division and department
  • Review billing issues with revenue manager
Clinical Operations Analyst
12/2013 - 11/2017
Philadelphia, PA
  • Screen and respond to telephone calls and inquires directing callers to appropriate individuals/departments
  • Collaborates with Associate Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program
  • Dependable transportation, valid driver’s license and automobile insurance coverage
  • %: The GPM works closely with EPT/LPT members to ensure timely completion of deliverables required to ensure robust and balanced cross-functional planning, decision-making, implementation and monitoring of global programs
  • %: The GPM contributes to the development and execution of cross-business initiatives and processes
  • 10% Managing processes of defined scope required for effective program management (if appropriate)
  • Global Development Lead (GDL) / Product Strategy Lead (PSL)
  • Product Strategy Program Manager
Clinical Operations Intern
09/2009 - 09/2013
San Francisco, CA
  • First line contact for providers regarding corrections and questions including inpatient billing
  • Prepare the Department for the transition to value-based medicine and population health by developing the necessary infrastructure to define, track, and present quality metrics in real time through the electronic health record
  • Ensure comprehensive and efficient onboarding for new physicians
  • Assist with designated administrative details, usually of a confidential nature, using initiative, discretion and judgment Independently manage calendars, contact databases and daily schedules
  • Schedule internal and external meetings of various sizes
  • Make travel arrangements (domestic and international) for selected senior team members and the Head of Global of Clinical Operations
  • Process travel reimbursements for selected senior team members and the Head of Global of Clinical Operations
  • Develops Trial Master File structure and collects and files content
  • Apply knowledge of function to address new projects or situations by adapting standard techniques whether of a technical or administrative nature

Education


Grand View University
2003 - 2008
Bachelor's Degree in Life Sciences

Professional Skills


  • Strong leadership skills are a prerequisite, including excellent interpersonal, communications, problem solving and negotiating skills
  • Proven excellent written and oral communication skills; acute listening skills
  • Significant clinical trial management experience with demonstrated success required. Strong leadership and negotiation skills
  • Strong interpersonal skills, written, and verbal communication skills
  • Strong organizational skills are required and computer skills are required
  • Positive communication skills (written and verbal), including lateral management, meeting management, and negotiation skills
  • Demonstrated analytical and strong organizational skills with perceptive attention to detail

How to write Clinical Operations Resume

Clinical Operations role is responsible for organizational, interpersonal, computer, leadership, clinical, microsoft, presentation, organization, planning, customer.
To write great resume for clinical operations job, your resume must include:

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

Contact Information For Clinical Operations Resume

The section contact information is important in your clinical operations 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 Clinical Operations Resume

The section work experience is an essential part of your clinical operations 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 clinical operations responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical operations position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Clinical Operations resume experience can include:

  • Good organizational skills, strong teamwork and very good communicative skills
  • Good oral and written communication skills; ability to work independently and as part of a team; strong analytical and problem solving skills
  • Advanced planning and project management skills, excellent time management, prioritization and organizational skills
  • Exceptional organizational skills, attention to detail and demonstrated human relations and effective communication skills required
  • Demonstrates effective project management skills including meeting project timelines, budgets and the ability to manage deadlines
  • Demonstrated ability to handle multiple competing priorities effectively ability to work in a fast paced and team-oriented environment

Education on a Clinical Operations Resume

Make sure to make education a priority on your clinical operations resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical operations 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 Clinical Operations Resume

When listing skills on your clinical operations 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 clinical operations skills:

  • Demonstrates exceptional communication skills by conveying necessary information accurately, listening effectively and seeking clarification when needed
  • Excellent communication, presentation and interpersonal skills, including good command of German and English language (both written and spoken)
  • Establish and maintain effective working relationships with excellent leadership skills
  • Displays excellent organization and time management skills, excellent attention to
  • Very strong operational leadership experience and skills
  • Broad clinical operational experience and strong project management skills

List of Typical Experience For a Clinical Operations Resume

1

Experience For Director of Clinical Operations Resume

  • Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership, prioritization and team building skills
  • Mentors and develops direct reports and others including helping them develop their leadership skills, become excellent problem solvers, and decision makers
  • Providing validation status updates to the Validation Lead
  • Successful experience leading and developing an effective team working with resources not under direct control
  • Industry setting, or four years of pharmaceutical/health care field experience including 1 year previous experience as a CRA
2

Experience For Clinical Operations Specialist Resume

  • Highly skilled in managing competing priorities
  • Demonstrated experience in strategic planning, project execution, control, risk and resource management for a globally networked organization is desirable
  • Basic skills in writing informed consent templates, protocol and other documents. Applies knowledge of regulatory requirements/SOPs to documents
  • Exceptional qualitative, quantitative, analytical, and problem-solving skills and attention to detail
  • Demonstrated experience facilitating clinical development process development in support of global company processes
  • Experience working independently on multiple projects with multiple priorities
  • Responsible for guiding site through leadership skills and positive attitude
  • Contribute to the development of Category sourcing that effectively engages and influences the Business
3

Experience For Clinical Operations Lead Resume

  • Possess problem solving skills, with the ability to develop and improve processes
  • Microsoft Office(or similar) skills including Word, Excel, PowerPoint, Visio, and Project
  • Proficient computer skills using Word, Excel, PowerPoint, MS Project, email and the internet are required
  • Analytical, synthesis and reporting skills
  • Possess outstanding English (oral and written) and Mathematical skills
4

Experience For Clinical Operations Director Resume

  • Appropriately and effectively communicates all concerns to operational management team
  • Training and experience in Project Planning and Management
  • Using good documentation practices in an FDA-regulated environment
  • Tracking and management of validation data
  • Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed
5

Experience For Clinical Operations Analyst Resume

  • Working knowledge of documentation management practices with good understanding of GCP and regulatory requirements for document retention
  • Managing clinical documents for multi-site studies, prioritize multiple tasks and/or projects with limited supervision
  • Precepting experience with new staff, formal and informal
  • Planning, management, implementation, and evaluation of operations/services to ensure quality, efficiency and cost effectiveness
  • Resolving project constraints and prioritization of tasks in alignment with the program
  • Experience with copying, collating, binding, desk top publishing and working with printers
  • Experience transcribing business requirements, scoping, planning and delivering projects and technical documentation
  • Demonstrates an understanding of regulatory requirements including a working knowledge of FDA GCP and ICH guidelines
6

Experience For Clinical Operations Coordinator Resume

  • Proficient prioritizing and driving projects to milestone completion supporting strategic programs
  • Demonstrated success identifying, negotiating and overseeing outsourced clinical operations services and vendors
  • Experience working in Healthcare Staffing/Timekeeping and informal or formal progressive leadership roles
  • IT Knowledge: Excellent working knowledge of computers, including Microsoft Office, electronic data capture monitoring systems (EDCMS), and database management
  • Experience conducting assessments and administering scales in a clinical/research setting
  • Extensive experience in designing, managing and interpreting clinical trials
  • Experienced in working with Marketing to translate trial results into product marketing strategies
7

Experience For Clinical Operations Leader Resume

  • Participates in projects to identify and develop more effective and efficient means of staffing projects and tracking project staff
  • Good understanding of overall Clinical product development, including management of phase 2/3 studies
  • Experience in successfully coordinating across several complex functions to ensure comprehensive and consistent planning and execution
  • Continuously interacts with all functions ensuring effective ongoing communications across teams and stakeholders
  • Experience with financial business case development, including working across functional groups to gain consensus on financial estimates
  • In depth knowledge of MS Project and good working knowledge of Microsoft Office programs including PowerPoint, Excel and Word
  • Strong understanding of partnering with vendors
  • Experience managing meeting budgets
8

Experience For Head of Clinical Operations Resume

  • Demonstrated ability of working with global and cross functional teams in a complex, changing environment to deliver value-added results to the organization
  • A strong working knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
  • Experience with developing SOPs and department processes, including the requirements for and interpretation of Clinical SOP’s
  • Experience with training and mentoring clinical research staff
  • Good understanding of Clinical Pharmacology testing and pre-clinical/clinical strategies in drug development
  • Strong English speaking and working in global environment
9

Experience For Senior Mgr, Clinical Operations Resume

  • Track vendor specific metrics from sources of advertising so that advertising strategies can be decided based on what is most effective
  • Experience in system testing, problem resolution, and training
  • Develop and maintain effective leadership and working relationships with all site personnel in accordance with the Company's policies and procedures
  • Experience in Sharepoint with filing systems is desirable
  • Experience with Sharepoint with filing systems is desirable
  • Strong working knowledge of Office 2007-13 and Visio
  • Demonstrated understanding of the case management process
  • Proven track record of ever-increasing responsibilities in a clinical development organization
10

Experience For Clinical Operations Supervisor Resume

  • Excellent knowledge of ICH/GCP including relevant Guidance documents from (FDA, ICH, and EMEA etc.)
  • Possesses a solid understanding of process improvement concepts, document standards, criteria and conventions
  • Demonstrate company values in all relationships (including suppliers)
  • Enable the company to get the best out of its Suppliers by working in partnership with them for mutual good business
  • Assist with coding validation efforts between data sources and countries
  • All aspects of competency validation and education according to divisional policies
  • Practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle

List of Typical Skills For a Clinical Operations Resume

1

Skills For Director of Clinical Operations Resume

  • Strong strategic planning, organizational skills, and negotiation and influencing skills
  • Additional soft skills include - able to work independently, strong interpersonal skills, able to multi-task, team player
  • Computer Processing Skills - ability to retrieve, add and update information from computer systems effectively to perform tasks accurately
  • Experience at effectively working with physicians both in employed and independent practices, with evidence of successes accomplished through partnerships
  • Good EMR skills. Experience using Flowcast and EPIC
  • A high orientation to detail with proven strong analytical and financial skills
  • Competent-to-expert skills in Microsoft Office with ability to acquire skills in other company-specific platforms
2

Skills For Clinical Operations Specialist Resume

  • Strong communication skills and interpersonal relationship demonstrated
  • Demonstrated excellent customer service skills with both internal and external customers required
  • Team collaboration skills; effectively work with multiple cultures and working styles
  • Broad clinical operational experience (registration and/or post-approval) and strong project management skills
  • Demonstrate leadership skills in building a quality recruiting department
  • Strong writing and communication skills, including the ability to tailor the same content to multiple audiences
  • Strong computer skills/data management capabilities including capability of managing of spreadsheets and data templates within various LIMS applications
3

Skills For Clinical Operations Lead Resume

  • Solid soft skills: customer service, sales, presenting
  • Solid interpersonal, written and verbal communication skills across study team including study management
  • Excellent organizational skills, rigor, striving for results, high accuracy orientated
  • Strong communication (verbal/written/listening) skills
  • Pharmaceutical, regulatory and labeling experience in a global regulatory environment or equivalent demonstrated knowledge strongly desired
  • Good presentation, communication and organizational skills
4

Skills For Clinical Operations Director Resume

  • Interpersonal and effective communication skills for a broad range of audiences
  • Strong analytical, problem identification and problem solving skills
  • Excellent interpersonal and communication skills, including medical terminology
  • Strong interpersonal skills and the ability to work with different levels of staff, patients and family members
  • Proven ability to communicate and present effectively to senior leaders, cross-functional and cross-organizational teams
5

Skills For Clinical Operations Analyst Resume

  • Strong leadership/management and analytic skills, ability to deliver on business initiatives in a timely manner
  • Shows attention to detail. Excellent Data Entry skills
  • Strong organizational skills, ability to manage and complete assigned projects on time
  • Project Management, Excellent communication skills
  • Or above site monitoring experience and at least 1 year project management experience. Better to have audit or inspection experience
  • Strong interpersonal skills and the ability to represent the business with both internal and external colleagues associated with the organization
6

Skills For Clinical Operations Coordinator Resume

  • Excellent computer skills (Microsoft Office Suite, Word, Excel, PowerPoint)
  • Strong written, oral, & interpersonal skills
  • Develop innovative, new solutions not presently used in order to more effectively identify patient subsets in a manner that is expeditious and cost effective
  • Good time management, planning and scheduling skills
  • Strong reading and language skills
  • Excellent communication skills, including all levels of management both locally and globally
  • Acquired Leadership experience/skills,
7

Skills For Clinical Operations Leader Resume

  • Strong interpersonal and written/oral communication skills to facilitate interaction with internal and external customers
  • Computer skills and technical aptitude, familiar with MS Office, good expertise in Excel & PowerPoint
  • Excellent communication, organizational and grammar skills
  • Proven ability to work proactively and effectively
  • Strong interpersonal communication skills including, formal presentations, meeting management, negotiation/persuasion and conflict resolution
  • Leadership & Project Management skills; positive, "can do" attitude, includes effective vendor and stakeholder management, risk management planning
  • Computer skills required for effective budget management, communication and representation of data/information
  • Effective oral and written communication and presentation skills in English and/or Japanese
  • Good organizational, communication, and teamwork skills
8

Skills For Head of Clinical Operations Resume

  • Highly Desired Skills/Experience
  • Project coordination experience and organization skills
  • Effectively prioritizes to complete tasks and avoid delays in work flow
  • Good communication, organization and computer skills are required
  • Strong interdepartmental communication, presentation, persuasion and negotiation skills
  • Facilitates clinical orientation, skills validation, and competency evaluation for new hires
9

Skills For Senior Mgr, Clinical Operations Resume

  • Facilitate new skills validation and annual competency evaluation
  • Strong English writing and oral presentation skills
  • Utilizes effective verbal and written communication skills with patients, families, staff, co-workers, management, physicians, and ancillary department staff
  • Effective oral and written communication skills to influence decisions, inform and guide a large global operational team
  • Some experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices
  • Ensure feasibility of translating evidence generated into real world effectiveness and cost effectiveness to support the MS brand
  • Experience in a role requiring demonstrated competency in education principles and an understanding of adult learning principles
  • Experience/Knowledge of good requirements gathering techniques including process mapping techniques. (Example LEAN, SIX SIGMA etc.)
10

Skills For Clinical Operations Supervisor Resume

  • Demonstrated experience writing, reviewing and editing protocols and clinical study reports
  • Five years of professional healthcare or experience in a clinical setting that demonstrates clinical expertise and understanding of healthcare systems
  • Demonstrated strength in facilitating projects, multiple tasks and priority setting
  • General troubleshooting, problem solving and analytical skills
  • Demonstrate creative thinking in suggesting new or more effective ways to recruit volunteers and patients for clinical trials
  • Demonstrated experience in a Chemistry and / or Micro testing lab executing test specifications with lab instrumentation

List of Typical Responsibilities For a Clinical Operations Resume

1

Responsibilities For Director of Clinical Operations Resume

  • Demonstrated strong communication skills, effective presentation skills, negotiation and influencing skills
  • Have excellent verbal and written communication skills and interpersonal skills
  • Successfully operate in an international environment and experience building effective working relationships across geographic locations
  • Strong leadership skills (persuasive, encouraging and motivating)
  • Demonstration of successful execution in a fast-paced environment managing multiple priorities effectively
  • Pharmaceutical, regulatory and labeling experience in a global regulatory environment or equivalent demonstrated knowledge strongly desired
  • Communicates effectively using a variety of mediums appropriate to the setting
2

Responsibilities For Clinical Operations Specialist Resume

  • Demonstrated experience managing multiple complex projects with different deadlines simultaneously
  • Strong experience working with MS Excel, Word, Outlook, PowerPoint, and SharePoint
  • Strong problem solving abilities with a strong work ethic and dedication to completion of assignments
  • Relationship management, communication ability, influencing skills required
  • Demonstrated ability to build effective working relationships with management team
3

Responsibilities For Clinical Operations Lead Resume

  • Critical thinking, data analysis and interpretation skills
  • Attention to detail with accurate proofreading skills
  • Strong familiarity with Physician Assistant Program Accreditation standards and have both Clinical and significant teaching experience
  • Proven track record of strong performance management and developing teams
  • Demonstrated lab experience of identifying continuous improvement opportunities
  • Data analysis and technical skills in the area of clinical trials/clinical data
  • Serves as a nursing advocate in advancing the spirit of team and in developing strong working relationships with physicians
  • Capable of balancing and managing multiple projects, each with varying priorities, timelines, and resources
4

Responsibilities For Clinical Operations Director Resume

  • Clinical trial experience (familiar with reading clinical trial protocols to guide coding decisions)
  • Support system validation and user acceptance testing (UAT) by following scripts provided by the CTMS team
  • Responsible for support of company training programs and clinical studies, including site audits and validation
  • Interacts through project updates and reviews with all stakeholders ensuring effective ongoing communications across teams and stakeholders
  • Be a strong technical resource relative to CDM and CDM supportive tools, programming and reporting environments
  • Excellent understanding of research methodology used in conducting health economics and outcomes research and real-world studies is required
5

Responsibilities For Clinical Operations Analyst Resume

  • Interacts through program updates and reviews ensuring effective ongoing communications across teams and stakeholders
  • Experience leading and managing teams/organizations
  • Contribute to ad hoc team productivity and efficiency by providing direction and facilitating good team dynamics
  • Experience training and mentoring clinical research staff; ability to lead teams and projects in a matrix environment
  • Previous experience working processing invoices to include review for accuracy
  • Several years of experience leading/coordinating Clinical Operations teams
  • Experience managing daily cash activity and reconciling income reports with daily payments
6

Responsibilities For Clinical Operations Coordinator Resume

  • Nursing experience in a clinical setting or,
  • Experience developing and implementing policies, procedures
  • Identifies on-going metrics and retention/hiring initiatives to validate allocations/utilization
  • Oversee the development of budgets and maintenance of operational monitoring processes to ensure maximum efficiency and effectiveness of operational units
  • Applies good clinical practice (GCP) principles and follows ICH guidelines to ensure all medical coding activities follow SOP's, WI's and associated guidelines
  • Strong understanding of adverse events, clinical sequelae, and risk assessment
7

Responsibilities For Clinical Operations Leader Resume

  • Strong working knowledge of US FDA, EU and GCP and local regulations
  • Experience working in Medical Affairs
  • Identifies opportunities for process improvement and value creation by using objective data-based evidence
  • Proven ability to work independently and maintain a high level of accuracy when completing all activities
  • 6 months to 3 years of experience working in a GMP environment
8

Responsibilities For Head of Clinical Operations Resume

  • Develops strong relationships with data experts, SMEs, project team members, vendors and partners to ensure the smooth and efficient running of the project
  • Strong understanding of regulatory data
  • Experience of data cleansing / migration initiatives, with both automated and manual approaches
  • Experience working in Regulatory environment and more broadly in the pharma industry
  • Experience working in Corporate/Office environment
  • Experience in using a computer required. Familiarity with common software programs (e.g., Word, Excel, and PowerPoint) required
9

Responsibilities For Senior Mgr, Clinical Operations Resume

  • Experience working in more than one therapeutic area
  • MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding
  • Good knowledge in planning and management tools
  • Think systematically with proven problem solving
  • Extensive clinical data management experience in Pharmaceutical or CRO setting
  • Experience working in a regulated laboratory environment is highly desirable
  • Experienced in product labeling and design
  • Previous experience leading an organization structure change program
  • Experience at working both independently and in a team-oriented, collaborative high pressure environment is essential
10

Responsibilities For Clinical Operations Supervisor Resume

  • Identifies sites using various evidence-based sources
  • Experience in product labeling
  • Experience leading cross?functional teams and projects
  • Experience working in a collaborative and cross-functional environment
  • Experience in the majority of the following: UPLC/ HPLC, GC, UV-Vis, Karl Fischer, IR, PSD, wet chemistry, and USP/EP compendial test procedures
  • Experience analyzing data and reports
  • Experience in healthcare (e.g. Medical Assistant or Pharmacy technician), or working in a similar role in an anticoagulation clinic
  • Excellent knowledge of statistical methodology and a working knowledge of computer systems

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