Clinical Trial Manager Resume Sample
Mariano Wilderman
624 Luettgen Plains,
Philadelphia,
PA
+1 (555) 525 6220
Work Experience
Clinical Trial Manager
10/2016
-
PRESENT
Dallas, TX
- Advanced knowledge of Clinical Trial Process (CTP) and development process
- Develops/manages clinical trial budgets independently
- Sets priorities with guidance
- Manages multiple projects with supervision
- Expert in communication / mentoring
- With 2+ years’ experience in project management skills as manager role, at least8 years’ experience in pharmaceutical/clinical research industry
- Project management/organizational skills. Solid computer skills requirement of MS applications including (but not limited to) MS Project, Word, Excel
- With 2+ years’ experience in project management skills, at least8 years’ experience in pharmaceutical/clinical research industry
Senior Clinical Trial Manager
12/2009
-
04/2016
Philadelphia, PA
- Experience within the clinical trial management field, with some experience of taking a lead CRA role in the management of studies/trials is acceptable
- Advanced knowledge of GCP/ICH and local guidelines, regulations and directive
- Conduct closeout site visits, including reviewing record retention requirements, investigational product reconciliation and securing and reviewing investigator’s final report
- Work effectively as part of an Integrated Product Team (IPT) and act as the Sponsor’s liaison to resolve site related issues quickly and effectively
- Oversee the planning and execution of clinical studies to ensure that deliverables are completed on time and within budget
- Develop and manage study related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools
- Interact with investigative sites through training and ongoing communication to ensure successful execution the clinical trial
Global Clinical Trial Manager
03/2005
-
11/2009
San Francisco, CA
- Assist with oversight of clinical trial monitoring including attendance at qualification, initiation, monitoring, and close-out visits as needed
- Oversee the appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
- Plan investigator and coordinator meetings and prepare and present meeting materials
- Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with corporate standards, regulations, and Good Clinical Practices
- Select and manage external vendors/CROs to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
- Participate on cross-functional core project team to ensure clinical deliverables are aligned with corporate objectives
- Develop an understanding of competitive landscapes for assigned products and therapeutic areas
- Demonstrate understanding of Lutonix general business functions, products, and procedures
- Coordinate the development and submission of clinical reports and abstracts/manuscripts
Education
National University - Fresno Campus
2000 - 2004
Bachelor's Degree in Science
Professional Skills
- Leadership skills/negotiation skills, Mentoring/coaching, Ability to effectively multi-task and prioritize
- Excellent written and verbal communication skills are required. Strong computer skills (MS Office) are required
- Presentation skills and influencing of others, written and oral communication skills, advanced technical writing skills
- Excellent written and oral communication skills, as well as conflict management, time management and organizational skills
- Time management skills – ability to effectively multi-task and prioritize,
- Strong organizational skills and ability to prioritize tasks and set and meet deadlines
- Demonstrated strong leadership skills and the ability to work successfully in a matrix team environment
How to write Clinical Trial Manager Resume
Clinical Trial Manager role is responsible for leadership, interpersonal, clinical, computer, organizational, research, presentation, english, pharmaceutical, database.
To write great resume for clinical trial manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Trial Manager Resume
The section contact information is important in your clinical trial manager 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
- Telephone number
Work Experience in Your Clinical Trial Manager Resume
The section work experience is an essential part of your clinical trial manager 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 trial manager 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 trial manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Trial Manager resume experience can include:
- Prior related clinical trial management experience including experience managing direct reports
- Strong IT skills to manage internal systems and reporting
- Demonstrated aptitude for strategic thinking skills
- Well-developed strong problem-solving skills
- Strong public speaking skills and ability to facilitate meetings
- Strong interpersonal and organizational skills and the ability to manage multiple tasks
Education on a Clinical Trial Manager Resume
Make sure to make education a priority on your clinical trial manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical trial manager 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 Trial Manager Resume
When listing skills on your clinical trial manager 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 trial manager skills:
- Effective project management skills, cross-functional team leadership and organizational skills
- Clinical research operational knowledge, strong project planning/management and excellent communication skills
- Effective leadership and delegation skills and validated ability to foster team productivity and cohesiveness is required
- Demonstrated strong computer skills (MS Office, MS Project, PowerPoint)
- Proven problem solving and decision making skills,
- Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization
List of Typical Experience For a Clinical Trial Manager Resume
1
Experience For Senior Clinical Trial Manager Resume
- Strong computer skills and high level of proficiency with Microsoft Office (e.g. Word, Excel,
- Strong project management, leadership and mediation skills within a matrix environment
- Demonstrated interpersonal & leadership skills
- Demonstrated skill in managing multiple tasks simultaneously, with attention to detail
- Previous strong Oncology and/or Medical Devices experience
- Clinical research experience combined with around 1 year of CTM experience
- Experience in a Lead CRA/Project Lead or equivalent role and 7+ years of total experience in the clinical research field
2
Experience For Global Clinical Trial Manager Resume
- Experience using and training others on various EDC systems
- Demonstrated knowledge of Electronic Data Capture systems, Monitoring Visits
- Experience working within a Quality Assurance and Regulatory departments.
- Strong understanding of the cost drivers, attuned to principles of cost disciplined science and are able to proactively manage the study budget
- Relevant industry experience in a clinical research setting
- Relevant industry experience (sponsor and CRO), including but not limited to CRO oversight for large-scale international programs
- Experience managing clinical trials in pharmaceutical and/or CRO
- Experience managing Ph II-III International clinical trials in Pharma/Biotech
3
Experience For Senior CRA / Clinical Trial Manager Resume
- Clinical trial research management experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting
- As a Clinical Monitor/CRA, as well as experience in data handling or analysis
- Experience in managing clinical research studies (4+ years for Sr. CTM)
- Experience in research setting desired
- Demonstrated professionalism and understanding of appropriate research study protocol
- CRM Clinical trial, Diagnostics (e.g. Heart Failure sensing) or technical experience desired
- Detail-oriented individual with good problem-solving capability
4
Experience For Clinical Trial Manager / Senior Manager Resume
- Experience in fast-moving company and are flexible and adaptable as requirements change
- Solid understanding of the Drug Development process, ICH guidelines/GCP & specifically each step within the Clinical Trial Process
- Experience in managing sites with in depth knowledge in local requirements and regulations in APAC Countries
- Five-years of experience leading
- Strong working knowledge of GCP/ICH
5
Experience For Clinical Trial Manager, Oncology Resume
- Strong organizational, planning and follow-through
- Experience in the Clinical Research Industry (8+ for Sr. CTM)
- Experience in the Clinical Research Industry
- Flex, develop and maintain expertise in JDRF research priority areas to be a clinical and operational resource to internal and external stakeholders
- Clinical research experience or course-work equivalent in clinical research
- Clinical trial management experience with in the pharmaceutical/biotech industry
- Experience as an on-site monitoring CRA and/or study coordinator
- Effective management of vendors to the required standards
6
Experience For Principal Clinical Trial Manager Resume
- Identifying resource needs and priorities within the product line and communicating updates to the Study Director
- Responsible for overseeing development of clinical databases, data management plans including data preparation, data validation activities, etc
- Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines
- Previous monitoring, study coordination, clinical project management experience
- Build effective and efficient high performing SMTs and ensure team members are aware of their accountabilities, responsibilities and deliverables
- Experience of site monitoring and study management responsibility is required
- Experience working in Medical Device or Diagnostic Research trials
- Handle and prioritize multiple tasks simultaneously,
7
Experience For Clinical Trial Manager, ICO Resume
- Proven track record of international study management
- Medical Device and/or diagnostics experience required
- Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics,
- Demonstrated working knowledge of cGCP, ICH and other relevant clinical development and FDA regulations and processes
- Demonstrated knowledge of and commitment to abiding by ethical standards in research
- Experience with data cleaning and database closure coordination
- Proven ability to successfully plan, implement, and manage global clinical trials
- Computer literate with experience in Microsoft Software suite, such as Word, Excel, Power Point and other relevant packages
- Experience as a Clinical Trial Manager
8
Experience For Clinical Trial Manager, CDx Resume
- Industry experience in Pharma, Biotech or CRO
- Structural Heart, Rhythm Management, or Interventional CardiologyClinical trial or technical experience desired
- Experience with peripheral vascular devices
- Master’s or PhD with experience in an applicable research environment; OR
- PharmD, BSN, Nurse Practitioner, or Physician Assistant with related clinical experience
- Previous Medical Device and or Oncology experience
- Significant pharmaceutical industry or clinical development/medicine experience
9
Experience For International Clinical Trial Manager Resume
- Related clinical trials experience
- Experience in clinical and drug development
- Proven ability to successfully plan, implement, and manage global clinical trials independently
- Preference for local (instead of international) experience
- Demonstrated knowledge of Electronic Data Capture, IRT, CTMS and eTMF systems
- Experience in managing sites with in depth knowledge in local requirements and regulations in Philippines
- Identify issues, analyze situations and provide effective solutions
10
Experience For Temp-clinical Trial Manager Resume
- Experiences in clinical development and/or medical affairs of pharmaceuticals and/or medical device industry
- Experience in clinical trial project management, even as a Sr. Clinical Research Associate/Specialist
- Above 4 years clinical operation experience in Medical Device/Pharmaceutical corporate or CRO (Clinical Research Organization)
- A proven track record within study management at a global level
- An ability to combine creativity, leadership and experience to empower a team to succeed
- Five-year of experience with clinical trials as a CRA or related
- Demonstrated superior communication and collaboration
List of Typical Skills For a Clinical Trial Manager Resume
1
Skills For Senior Clinical Trial Manager Resume
- Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation of skills is required
- Demonstrated success in using oral and written communication skills to influence, inform, or guide others,
- Effective team player and exceptional written and interpersonal communication skills
- Proven ability to effectively manage CROs and clinical study vendors
- Highly effective verbal and written communication and presentation skills in English
2
Skills For Global Clinical Trial Manager Resume
- Exceptional interpersonal skills with proven successful team participation
- Ideally 5+ years pharmaceutical industry experience with 3-5 years’ strong experience in clinical research
- Demonstrated ability to work effectively on cross-functional team
- Effective oral and written communication, and interpersonal skills are required
- Highly effective interpersonal and written communication and presentation skills
- Demonstrated leadership skills in multi-disciplinary
- Financial budgeting and forecasting skills,
- Proficiency in MS office including Word, Excel, PowerPoint and other applications; demonstrated experience in technical writing
3
Skills For Senior CRA / Clinical Trial Manager Resume
- Experience in global clinical trial operations including experience developing protocols and key study documents
- Sound critical thinking and problem solving skills
- Communicate study related issues and Lessons Learned effectively within the CTM group (CTM meeting, Action list)
- Well-developed and strong problem-solving skill
- Demonstrated experience performing clinical trial management
- Prior experience working with NIH-funded grants desired
4
Skills For Clinical Trial Manager / Senior Manager Resume
- Strong project planning/management experience is required
- Demonstrated experience in presenting to stakeholders is required
- >3 years’ of clinical research experience, in the pharmaceutical industry with a solid understanding of technology and processes used in drug development
- Advanced computer skills including proficiency in MS Office are required
- >3 years of clinical research experience, in the pharmaceutical industry with a solid understanding of technology and processes used in drug development
5
Skills For Clinical Trial Manager, Oncology Resume
- Demonstrated experience managing CROs and other specialty vendors is essential
- Prior related clinical trial management experience including people management
- Clinical trial project management skills,
- Leadership / influence management skills,
- Effectively lead a cross-functional team in a matrix environment,
- Experience in multi-phase studies which includes site feasibility/selection through late phase - US and International experience
- Effectively interface with multiple teams in a variety of locations
- Effectively collaborate across multiple clinical and non-clinical functions
6
Skills For Principal Clinical Trial Manager Resume
- Demonstrated experience in presenting to stakeholders and stakeholder management is required
- Previous strong Oncology experience . Dermatology and/or Medical Devices also would be advantageous
- Experience in Clinical Project Lead/Management or equivalent roles and 7+ years of total experience in the clinical research field
- Experience in Clinical Project Lead/Management or equivalent roles and 8+ years of total experience in the clinical research field
- Large experiences in Clinical Trial Management, recognized leader and strong core competencies without significant deficiencies
- Work effectively in a team/matrix environment,
- Proven experience of vendor management and budget oversight
- Lead and work effectively in a global team/matrix environment on multiple projects
- Experience in clinical study or program management, including study start-up, conduct, and close-out of trials (level determined by experience)
7
Skills For Clinical Trial Manager, ICO Resume
- Effectively interact with all levels of
- Able to collaborate effectively with the study team, cross-functional team members, and external partners
- CRA experience and 2 years of study management experience
- Satisfactory progression from monitoring experience with previous experience in leadership and/or management activities
- Experience in clinical operations and experience with complex clinical trials
- Provides study leadership and effectively collaborates with other departments within CR&D to meet study timelines and goals
- Experience in field monitoring, strong knowledge of clinical trial processes and guidelines
- Familiar with advanced concepts of clinical research and able to work effectively in a dynamic team/matrix environment
- Desired soft-skills: Flexible, detail-oriented, innovative, diplomatic, and efficient
8
Skills For Clinical Trial Manager, CDx Resume
- Experience in developing, planning and executing clinical projects
- Work experience in the healthcare or clinical trial industry monitoring and managing clinical trials
- Pharmaceutical /biotech industry experience in areas of clinical trial design, data management, study management, study monitoring and reporting
- Relevant experience in pharmaceutical packaging and labeling
- Work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination
- Experience working with study budgets and forecasting; contract and invoice review
- Experience in mentoring and/or supervising junior staff
9
Skills For International Clinical Trial Manager Resume
- Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors)
- Deep understanding of clinical drug development processes and experience applying GCP, ICH and FDA requirements
- Demonstrate appropriate judgment in making decisions/seeking supervisor support
- Develops and maintains effective working relationships with people across cultures
- Places a priority on getting results with an emphasis on high quality outcomes,
10
Skills For Temp-clinical Trial Manager Resume
- Develops and maintains effective working relationships with people across cultures and organizations,
- Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required
- Develops and maintains effective working relationships with people across cultures,
- Extensive experience in all aspects of clinical trial planning and start up
- Experience executing the complete range of clinical trial activities, from start up through final trial report
- Make study budget proposal based on fair market value. Ensure the study is operated according to the budget
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines
List of Typical Responsibilities For a Clinical Trial Manager Resume
1
Responsibilities For Senior Clinical Trial Manager Resume
- Provides on-site clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during use of the company’s medical devices during clinical investigations and post-market studies
- Create required project plans; implement and monitor progress against project plans and revise as necessary; review clinical protocols, CRF’s, study reports, and informed consent forms
- The contractor shall monitor project tasks, timelines, and deliverables from project planning and initiation to close out for all on- going and planned clinical trials
- International trial management experience
- BA/BS and 5 or more years of experience with direct clinical trial management, including management of vendors and CROs
- Training and Investigator Meeting
- Working knowledge of GCP, ICH and relevant CFRs is required
- Create appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed
- Approximately 10% travel, primarily involving trips to conferences for site visits, conferences, Investigator meetings or co-monitoring
2
Responsibilities For Global Clinical Trial Manager Resume
- Maintenance/updating of data as appropriate in project management tools including CTMS
- Financial planning and tracking
- Ensure investigational studies of Avid’s molecular imaging agents, adhere to FDA regulations, ICH GCP guidelines and Avid’s internal SOPs
- Manages junior staff i.e.: CRAs / CRA IIs / CTA’s performing site management efforts
- Initiates and participates in leading departmental or interdepartmental strategic initiatives and process improvements
- Organize and coordinate documentation related to clinical IVD studies being conducted in China both for China approval and globally
- Proficient in MSOffice including, Outlook, Word, Excel, Access, PowerPoint and MSProject
- Travel up to 25% of the time including some weekends
- In collaboration with medical director for study, creates and leads the development of study plans and study specific working practices
3
Responsibilities For Senior CRA / Clinical Trial Manager Resume
- Contributes to ongoing process initiatives
- Independently and proactively manage multiple ongoing activities at once
- Oversight of study execution utilizing available performance metrics and quality indicators
- Ensures required reports are generated and available for real time tracking of trial status
- The contractor shall notify the team of potential clinical trial risks and propose appropriate corrective course of action for risk mitigation
- The contractor shall provide written and verbal reports on status of clinical trials and significant issues impacting clinical trials at a frequency requested by the Government team lead
- The contractor shall develop tools for management, monitoring, and reporting on status of clinical trials
4
Responsibilities For Clinical Trial Manager / Senior Manager Resume
- Manages study team activities, including; investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports, consistent with approved budgets/timelines
- Manages and/or oversees the management of study sites, ensuring protocol and regulatory compliance
- Works with clinical contracting group in development of RFPs and vendor selection
- Manages a staff who oversee multiple vendors, including; clinical services, IXRS, and central laboratory services. Responsible for ensuring external service providers execute activities in a quality manner and per the established contract
- Management responsibility for ensuring SOP and regulatory compliance of staff and study teams on one or more trials
- Participates in the development and review of study plans (e.g. CMP, DMP, SMP), study reports, protocols, ICFs, sections for Investigator's brochures, and other regulatory documents (e.g., IND, NDA or BLA) on one or more trials
- Manages investigational product and clinical supply needs
- Assist with the coordination of data review with cross functional team to support database lock
- Manages team quality issues with investigational sites and/or vendors
5
Responsibilities For Clinical Trial Manager, Oncology Resume
- Manage direct reports (Clinical Trial Assistant’s (CTAs) Clinical Research Associates (CRA’s)
- Accountable for the management of core processes (e.g. Site management, investigator notification letters, protocol deviations, study feasibility and enrollment) with input from key stakeholders
- Accountable for managing the Trial Master File setup and ensures ongoing maintenance of TMF documents and documentation process/plan
- Accountable for initiating and managing Pre Inspection Audit Readiness considerations for an assigned trial
- Accountable for the development of final Study/Country/Site Feasibility which informs final study timelines and budget
6
Responsibilities For Principal Clinical Trial Manager Resume
- Supports the Sr. CTM/operational study lead in collaborating with clinical affairs and other functions, and responsible for, the execution and delivery of studies (e.g. Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance)
- Responsible for the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as FRI’s SOPs and policies
- Experience in clinical study or program management, including study start-up, conduct, and close-out of trials (level determined by experience)
- Communicate with international teams; good English-language skills, both written and oral, is required
- Professionalism in all aspects of interactions and communication skills with internal colleagues, clinical study lab sites and pharmaceutical partners
- Demonstrated knowledge of FDA regulations and Good Clinical Practice (GCP) Guidelines as they relate to protection of human subjects
- Successful completion of an accredited Clinical Trial Certification course
- Primary contact for CROs Clinical Trial Site Monitoring Team to ensure CRO’s performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work
7
Responsibilities For Clinical Trial Manager, ICO Resume
- Work with department directors to set goals for the clinical trial management team
- Problem-solve clinical team personnel issues
- Manage internal (dotted line or functional) and external Clinical Research Associates (CRAs), and other external clinical trial service vendors as necessary. Provide timely feedback to assigned staff on personal and project-specific performance, and provide guidance on performance improvements as necessary
- Perform performance evaluations and provide assigned staff with constructive feedback to enhance their performance.Serve as mentor to help assigned staff develop their career paths
- Experience in Phase II-IV clinical trials
8
Responsibilities For Clinical Trial Manager, CDx Resume
- Ensure staff training is adequate and documentation of training is up to date
- Leads cross-functional study team (s) and/or sub-team(s)
- Develops study team charter and mission
- Leads, trains and mentors CRA’s/CTAs and CTMs
- Acts as point of escalation for study related issues
9
Responsibilities For International Clinical Trial Manager Resume
- Takes ownership and accountability for the Development/management/reconciliation of overall study budget(s)
- Chair clinical trial meetings-updating clinical staff and upper management on patient recruitment, trial issues, investigator’s feedback, monitoring issues, patient enrollment issues and presenting a plan of action for resolution of issues
- Provide oversight of the CRO to ensure compliance with Merrimack’s quality measures
- Study Team Leadership - Lead cross-functional study team and/or sub-team, develop, manage and
- Input Clinical Database, Safety and CSR Reports - Review edit specifications (paper and EDC),
10
Responsibilities For Temp-clinical Trial Manager Resume
- Development/management/reconciliation of overall study budget(s)
- Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
- Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation
- Leads the cross-functional study execution team to ensure that project milestones are met and adhere to approved budgets and are in compliance with ICH/GCP and local Regulatory Authorities’ guidelines
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