Clinical Project Manager Resume Sample

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Randall Little
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Work Experience


Clinical Project Manager
03/2016 - PRESENT
Dallas, TX
  • Responding to inquiries in a professional, courteous and timely manner
  • Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
  • Establishing and enforcing departmental standards
  • Reviewing and updating company SOPs related
  • Collaborates with Vendor Management, clinical team and regional groups to identify vendors and provides oversight of CRO performing the clinical operations functions for the clinical trials within the program
  • Ensures that the study logistics related to vendors (IVRS/ Central Lab etc) in protocol, are consistent with other study documents
  • Communicates the timeline and deliverables to the vendors
  • Establishes the budgets for each of the studies within the clinical program with assistance from finance, the regional group and in collaboration with the operational center
  • Participates and/or Arranges for the Protocol Feasibility within GCO
Senior Clinical Project Manager
01/2010 - 01/2016
Houston, TX
  • Participates in the review of the protocol and provides input from an operational perspective Distributes study protocol to the CRO or all participating countries & related parties. Collects and communicates reasons for a protocol change to responsible author on behalf of GCO
  • Approves final case report form design
  • Reviews and approves Clinical Trial Agreements and other contracts required to conduct programs that cannot be completed by the vendor
  • Provides/Establishes parameters for the final investigator fees and Pass Through expenses
  • Leads the vendor selection team and works closely with Strategic Sourcing personnel to identify and manage CROs, vendors, and consultants
  • Reading, understanding and adhering to organizational Standard Operating Procedures (SOPs)
  • Participating in the modification of company SOPs and/or Process Documents related to the therapeutic team
  • Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives
  • Communicating job expectations to APM’s
Assistant Clinical Project Manager
04/2005 - 11/2009
Los Angeles, CA
  • Responsible to ensure sites are ‘GCP’ compliant and following local and regulatory guidelines
  • Good project management skills thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process
  • Resolve issues with minimal supervision and understand when to escalate. Willingness to act accountably in project / trial management
  • Demonstrated leadership skills and the ability to solve problems proactively
  • Equivalent level of education and experience
  • Clinical Monitoring or Data Management experience required
  • Excellent and demonstrated verbal and written communication and presentation skills
  • Work independently, prioritize and work with in a matrix team environment is essential

Education


Grand View University
2000 - 2005
Bachelor's Degree in Life Sciences

Professional Skills


  • Demonstrate excellent multiple tasking skills in a matrixed team environment with the ability to shift priorities effectively
  • Demonstrate excellent critical thinking, time management and organizational skills to meet multiple deadlines, conflicting priorities and demanding workload
  • Proven leadership skills, executive presence, maturity, emotional intelligence, and written/oral communication skills
  • Interpersonal skills, including ability to build strong working relationships and effectively manage and resolve conflict
  • Strong prioritisation, problem solving and time management skills
  • Proven complex problem solving and decision making skills
  • Demonstrated strengths in planning, organizational, analytical skills, time management, problem solving, and attention to detail

How to write Clinical Project Manager Resume

Clinical Project Manager role is responsible for interpersonal, organizational, clinical, leadership, negotiation, presentation, computer, organization, software, research.
To write great resume for clinical project manager job, your resume must include:

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

Contact Information For Clinical Project Manager Resume

The section contact information is important in your clinical project 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
  • Email
  • Telephone number

Work Experience in Your Clinical Project Manager Resume

The section work experience is an essential part of your clinical project 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 project 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 project manager position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Clinical Project Manager resume experience can include:

  • Strong communication and presentation skills - Demonstrates strong written and verbal communication skills
  • Above-average communication skills as well as pronounced service orientation and negotiation skills
  • Good quantitative skills and working understanding of project budgets
  • Strong interpersonal, verbal and written communications and presentation skills
  • Prioritize projects and assigned tasks effectively
  • Excellent written and interpersonal communication skills necessary to interface with outside vendors, consultants, and team members

Education on a Clinical Project Manager Resume

Make sure to make education a priority on your clinical project 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 project 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 Project Manager Resume

When listing skills on your clinical project 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 project manager skills:

  • Strong leadership, communication, management and organizational skills, conflict resolution, and team building skills
  • Demonstrated leadership skills, organizational skills, and attention to detail
  • Strong prioritization, decision-making and adaptability skills. Ability to manage complexity. Flexible and able to work well in a changing environment
  • Strong leadership and management skills, with experience of managing cross-functional project teams
  • Excellent and demonstrated organizational and interpersonal skills
  • Superior interpersonal and communication skills sufficient to effectively create relationships to support the mission and vision of the RAVEN project

List of Typical Experience For a Clinical Project Manager Resume

1

Experience For Senior Clinical Project Manager Resume

  • Excellent written and oral communication skills, organization, interpersonal skills, and ability to work with people from a variety of backgrounds
  • Excellent process knowledge, experience, and skills
  • Demonstrated skills in leadership and in the areas of judgement, attention to detail, problem-solving, analysis, negotiation, and innovation
  • Clinical study experience, including prior experience with medical device trials
  •  Strong software and computer skills, including MS Office applications
2

Experience For Associate Clinical Project Manager Resume

  • Detail oriented, performance driven, strong decision-making skills
  • Excellent written and verbal communication skills, including proficiency in medical terminology
  • Good computer skills in word processing, presentation and calculation software
  • Excellent professional writing and verbal communication skills
  • Initiative, excellent attention to detail, with highly-developed organizational, and time-management skills are required
  • Experience of pharmaceutical experience and have prior involvement with multi-center, multinational Phase 3 trials
3

Experience For Assistant Clinical Project Manager Resume

  • Team player with strong interpersonal and collaboration skills
  • Experience and demonstrated success in sample testing by using serology assays and other bio-analytical methods
  • With more than 5 years of clinical trial operation experience within pharmaceutical or CRO, including 1 year experience on project management
  • Demonstrated Clinical Monitoring and/or Data Management experience required
  • Proven experience developing presentation materials for an executive audience
4

Experience For Clinical Project Manager, Early Phase Resume

  • Demonstrated experience with computerized systems, database management, and spreadsheet and word processing programs to manipulate data and create reports
  • Demonstrated research experience to include at least 3 years as a study coordinator / Project Associate / Clinical Research Associate (CRA) / Lead CRA
  • Interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance
  • Have a strong ability to prioritize with multiple, competing deadlines
  • Work effectively in a fast paced, dynamic environment
  • Maintain organizational skills and attention to detail
5

Experience For Clinical Project Manager Careallies Resume

  • Coordinate, implement and support activities needed to effectively execute clinical initiatives and special projects
  • Resourceful with heightened analytical abilities and problem solving skills in a fast paced
  • Demonstrated effective leadership within cross functional teams both internal and external to Emergent
  • Possesses exceptional written and oral communication skills
  • Communicates clearly and effectively across all levels of the organization
  • Ideally five years clinical research experience with two years project management experience
  • Extensive clinical research experience with global project management experience
6

Experience For CRD Associate Clinical Project Manager Resume

  • Ideally seven years clinical research experience with four years project management experience
  • At least, 10 years experience in clinical development and experience of one or more NDAs, or equivalent knowledge of clinical development
  • Experience managing and leading a successful optimization, integration or imaging project within a clinical systems portfolio (PACS, Imaging, EMR)
  • Experience in planning, managing and implementing Clinical initiatives
  • Ensures adequate study team resources and leads study team chartering to ensure that study team structure, including sub-teams, are effective and efficient
  • Fosters optimal study team health including formal team effectiveness assessments and action planning
  • Experience and high proficiency with electronic filing, data systems and reporting
  • Experience in understanding of key drivers impacting budgets
  • Experience developing status reports
7

Experience For RN Clinical Project Manager Resume

  • Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
  • Strong working knowledge of medical/scientific terminology and knowledge of ICH-GCP guidelines
  • Previous project management, clinical study coordination, clinical data management, or research subcontracting experience
  • Experience with implementing CTMS / EDC systems
  • Strong ability to draw sound conclusions from data and to function as a contributing team member
  • Previous project management experience and/or clinical trial management including data management
  • Proven ability to work autonomously on complex projects where critical thinking and innovative solutions are required
  • Experience in healthcare vertical including EMR, Health Insurance, Acute care, Post-Acute, Health Systems, and HIE
  • Experience with writing business requirements for clinical data applications and data interfaces
8

Experience For Bexm Clinical Project Manager Resume

  • Project management experience using data and information to make business decisions
  • Previous experience communicating to clients / external constituents
  • Good working knowledge of Code of Federal Regulation (CFR) and ISO requirements
  • Experience leading clinical projects end to end
  • Demonstrated success driving a clinical strategy forward
  • Experience working with RA trials (preferably early phase)
9

Experience For Senior Manager, Clinical Project Manager Resume

  • Experience working with early phase oncology trials (I-IIa)
  • Strong ability to deal with an evolving and change-oriented environment, highly flexible
  • Experience (5+ years) working in clinical research within a pharmaceutical company or CRO or
  • High attention to detail with ability to manage multiple competing priorities
  • Evidence of training in ICH GCP and ISO 14155
  • Previous experience in managing people within a scientific/clinical environment is required
  • Knowledge of Good Clinical Practices (GCP) and FDA regulations governing the conduct of clinical trials
  • Ability/experience in working in functional teams with several persons and various cultures
  • Experience in authoring of clinical investigation plans and other study documents required
10

Experience For Clinical Project Manager, Gcto Resume

  • Experience in authoring of standard procedures and investigator brochures is an asset
  • Previous experience leading large-scale research and quality improvement projects is required
  • Work experience leading clinical/hospital related special projects
  • Excellent team player with global mindset in a multicultural environment
  • Responsible for cross-functional team communication and effectiveness
  • Facilitate effective decision making
  • Organizational awareness to operate in a cross-functional team
  • Experience with industry technology including Electronic Data Capture (EDC) systems and web-based communications and community tools

List of Typical Skills For a Clinical Project Manager Resume

1

Skills For Senior Clinical Project Manager Resume

  • Review the clinical study protocol and supporting documents– Statistical Analysis Plan, CRFs, Data Management Plan, Clinical Study Report, monitoring plan, communication plan, timeline, etc. to ensure seamless integration between clinical objectives and study performance
  • 7 yrs of clinical trials experience including 3 years experience in project management; or equivalent combination of education, training and experience
  • Displays effective communication skills (listening, oral, and written) and can communicate in the English language (oral, written)
  • Prior experience and demonstrated success in working with PIs and research coordinator teams required
  • Excellent organizational, leadership, and problem-solving skills
  • Strong organizational and navigation skills within an enterprise healthcare environment
  • Read, write and speak fluent English; excellent verbal and written communication skills
  • Strong communication skills- ability to work independently and to take responsibility for own projects/tasks
  • Project management skills required to include the use of a formal process and system for planning and tracking ongoing progress of clinical projects
2

Skills For Associate Clinical Project Manager Resume

  • Strategic thinking and targeted problem solving skills
  • Demonstrated experience in leading operational change and applying lessons learned from one project to the next
  • Proven experience in leading & coordinating the activities of cross-functional operational teams and communication with internal & external trial stakeholders
  • Effectively interface with CBI marketing partners and their subject matter experts during PMS and PMCF activities
  • Communicates effectively with PM Leads, CHI management and stakeholders regarding project status
  • Deal effectively in all business relationships while projecting a positive image of the Company
  • Self-motivated, adaptable to a dynamic environment, flexible, open to change, and willing to learn new skills when required
  • Effectively communicate and influence all levels of stakeholders
3

Skills For Assistant Clinical Project Manager Resume

  • Develop and effectively manage budgets, timelines, and resources for assigned clinical studies and escalate variances within the established processes
  • Project management experience and 7+ years of total IT/project management experience required
  • Individuals with previous flow cytometry experience or clinical laboratory experience
  • Natural leader who knows how to delegate responsibilities effectively
  • Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization
  • Develops deep skills in specific project management functions and for key types of projects
  • Assists in the completion of clinical trial reports (CTRs) and performs final editing/proofing prior to publishing
  • Experienced in evaluating work performed against Scope of Work (SOW) documentation and leading study tasks with minimal clinical manager oversight
  • Flexible with the ability to prioritize tasks and multiple projects on an ongoing basis, and adapt easily to quickly changing situations
4

Skills For Clinical Project Manager, Early Phase Resume

  • Experience in building a Clinical Trial Budget and managing project to budget
  • Experience in building a Clinical Trial Budget and managing project to budgetN: Not Applicable - 不适用 (China)
  • 2) Experience Managing projects within a clinical systems portfolio (PACS, Imaging, EMR)
  • GCP (Good Clinical Practice) training OR the ability to complete appropriate GCP training within 60 days of hire
  • Effective in presenting information and responding to questions from project teams, external vendors and clients
  • Wound healing experience preferable; familiarity with wound healing literature and protocols
  • Solid working knowledge of current technologies & methods, including [Business Process Management, Collaboration tools, etc.]
5

Skills For Clinical Project Manager Careallies Resume

  • Demonstrate Leader Behaviors in motivating and supporting the study team
  • Experience preparing and delivering presentations to senior leadership team
  • Experience in budgeting and resource planning
  • Experience in building a CTB and managing project to budget
  • Experience programming with JavaScript or another scripting language
  • Experience in conducting literature reviews and writing clinical reports
  • Experience with regulatory submissions and a working knowledge of specific government agency requirements, and FDA’s current trial guidance
  • Demonstrated proficiency in Windows® and Microsoft® Office Suite including Word®, Excel®, and Outlook®
  • Ensure all auxiliary documents, including investigator brochure, statistical analysis plan, data validation plan, etc. are available
6

Skills For CRD Associate Clinical Project Manager Resume

  • Experience with budget and financial tracking of activities
  • Experience in managing all stages of study conduct (start-up, maintenance and completion)
  • Experience in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology
  • Proven project management expertise, including the leadership and development of cross functional teams and study team leadership
  • Previous experience managing clinical studies in Women’s Health
  • Experience with implementing project management best practices and
  • Individuals with experience managing medium to large size clinical studies budgets are highly desired
7

Skills For RN Clinical Project Manager Resume

  • Excellent working knowledge of MS Office (Word, Excel, Power Point)
  • Experience working in relevant clinical research preferably in clinical operations within a pharmaceutical company or CRO or similar organization
  • Interact with key study investigators to establish effective working relationship
  • Experience working with adult and geriatric patients required
  • Experience leading pediatric clinical trials in compliance with FDA regulations
  • Works under minimal supervision; requires ability to exercise critical thinking and good judgement
  • Proven ability exercise sound judgment in independent decision making
8

Skills For Bexm Clinical Project Manager Resume

  • Experience working in a team settings
  • Cooperate with document specialists regarding study files
  • Experience writing clinical protocols and other technical documents
  • Experience writing clinical protocols or other technical documents
  • At least three years’ relevant experience in clinical development including team leadership
  • : Global project management experience
9

Skills For Senior Manager, Clinical Project Manager Resume

  • Administrative experience required
  • Experience in clinical research and project management
  • Need to have a wide variety of healthcare applications experience, multiple vendors
  • Experience in all of the project management disciplines described in the Responsibilities – General section of this profile is required
  • Proven track record in clinical project leadership desired
  • Individuals with previous direct clinical trials experience, preferably within an IVD and medical device industry are highly desired
10

Skills For Clinical Project Manager, Gcto Resume

  • Strong understanding of cosmetic development process and global environment (regulation, skin investigational technologies, ...)
  • Individuals with experience in Risk Analysis, Human Factor and/or Health Economics evaluations
  • Strong technology background, specifically in infrastructure and EMRs
  • Demonstrated ability to build a project team environment of open collaboration within a pharmaceutical, biotechnology or CRO organization
  • Demonstrated ability to integrate and mobilize individual team members to achieve project goals
  • Clinical trial experience
  • Experience (at any belt level) with six sigma

List of Typical Responsibilities For a Clinical Project Manager Resume

1

Responsibilities For Senior Clinical Project Manager Resume

  • Excellent oral and written communication skills including strong presentation skills
  • Demonstrated effective verbal, written, and presentation communication skills
  • Demonstrated experience working with the Microsoft suite of programs. Good understanding of clinical study related software (eCRFs, IWRS, and CTMS)
  • Significant experience in clinical operations including strong clinical project management experience or equivalent
  • Can effectively plan and deliver a dynamic and persuasive presentation, using effective graphics, or slides
  • Demonstrated leadership skills - successfully managed large project teams
  • Strong project management skills with focus on study deliverables, trial oversight, quality and timelines
2

Responsibilities For Associate Clinical Project Manager Resume

  • Excellent written, verbal, computer, and organizational skills
  • Demonstrated financial management skills required
  • Have strong, enthusiastic communication, influencing and negotiation skills to drive successful outcomes across internal and external partners
  • Solid skills in the areas of judgment, problem-solving, leadership, analysis, negotiation, and innovation
  • Excellent verbal and written communication and presentation skills in German and English
3

Responsibilities For Assistant Clinical Project Manager Resume

  • Clinical research experience including 2 years' project management experience and experience in clinical operations
  • Strong computer skills, with proficiency in Microsoft Office applications
  • Work effectively with multi-level teams, manage multiple projects and work in a fast paced and changing environment
  • Experience working in a similar capacity, with proven track record in proactive study management
  • Demonstrates diplomacy and respect for others. Acts as a buffer for the team, providing focus and appropriate prioritization. Facilitates decision making
4

Responsibilities For Clinical Project Manager, Early Phase Resume

  • Computer skills with ability using clinical trial management systems, clinical trial databases, and electronic data capture
  • Detailed oriented with proven ability to prioritize multiple tasks and adjust work to meet service standards
  • Have proven experience in delivering Oncology studies across all phases
  • Time Management, uses time effectively and efficiently & values time
  • Strong preference of five years clinical research experience
  • Communication –written and oral skills
  • The ability be flexible in prioritizing tasks and multiple projects on an ongoing basis, and adapt easily to quickly changing situations
  • Experience evaluating work performed against Scope of Work (SOW) documentation and leading study tasks with minimal clinical manager oversight
5

Responsibilities For Clinical Project Manager Careallies Resume

  • Demonstrated competence in analysis, planning, and problem solving
  • Comfortable in a hospital environment, with experience working with nurses and surgeons
  • Experience (8+ years) working in relevant clinical research preferably in clinical operations within a pharmaceutical company or CRO or similar organization
  • Ubmission publishing experience
  • Experience working at or with registry or clinical trial sites
  • Develops and maintains strong working relationships with internal and external clinical site staf and KOLs and communicates regularly
  • ≥ 5 years experience in a project team position or working within the health sciences field in a similar positions
6

Responsibilities For CRD Associate Clinical Project Manager Resume

  • Respond quickly to changing priorities and opportunities
  • Experience in US GAAP would be an advantage
  • Is an expert on assigned protocols. Demonstrates ability to integrate and summarize medical/scientific concepts in protocols and other documents
  • Build and maintain strong pharmaceutical industry sponsor and organizational team relationships for the success of clinical trial management
  • Promote effective teamwork among functional teams and provide day to day direction for core team
  • Provides realistic timelines, states practical and valid operational models
  • Clinical Trial experience
  • Previous experience in the Medical Device field required
7

Responsibilities For RN Clinical Project Manager Resume

  • Device Trial and Financial Management experience required
  • Experience in project management required
  • Experience with risk based trial management is an asset
  • Demonstrates ability to influence others to achieve positive results and collaboration
  • Previous experience supporting development of scientific publication strategy
  • Global clinical trial experience and the ability to lead/manage more than one clinical trial
  • Previous Pharmaceutical or Biotech industry experience, ideally in a clnical development or clinical operations capacity, is required
8

Responsibilities For Bexm Clinical Project Manager Resume

  • Proven ability to work independently in a complex matrix environment
  • Thorough knowledge of Good Clinical Practice, and global clinical development processes
  • Experience with budget and resource management
  • Proven success as a manager of people and projects
  • Proven ability to solve problem and mitigate issues
  • Experience in a related role
  • Trial management experience in the pharmaceutical or CRO industry
  • Experience in relevant field
  • Clinical operations experience
9

Responsibilities For Senior Manager, Clinical Project Manager Resume

  • Oncology clinical trial experience [data or clinical management]
  • Experience with managing multiple concurrent clinical studies and clinical teams
  • Bid Defence experience
  • Oncology project leadership experience
  • Experience in Immuno-oncology; CAR-T; Hematological Oncology; Biosimilars
  • Previous CRO and Bid Defense experience
10

Responsibilities For Clinical Project Manager, Gcto Resume

  • Or 6 to 8 years related work experience as a clinical research project manager
  • Clinical trial management experience in cardiovascular area
  • Demonstrated ability to create project plans, schedules, communications and updates
  • Demonstrated ability to define, document and translate business/data requirements
  • Experience as a CRA in Phase I-III clinical trials
  • Project Management / Product Development experience
  • Strong knowledge of the insurance industry required
  • Health care experience

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