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Become A Clinical Project Manager

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Working As A Clinical Project Manager

  • Getting Information
  • Establishing and Maintaining Interpersonal Relationships
  • Making Decisions and Solving Problems
  • Organizing, Planning, and Prioritizing Work
  • Updating and Using Relevant Knowledge
  • Mostly Sitting

  • $133,270

    Average Salary

What Does A Clinical Project Manager Do At Kelly Services

* Leading, coordinating and managing multiple OMA/GMA projects/initiatives from conception through completion in accordance to corporate policies and procedures
* Ensuring all projects/initiatives milestones are on-time and within scope
* Advising key stakeholders on project/initiative performance using appropriate systems, tools and techniques
* Serving as liaison between OMA/GMA, cross-functional business partners and key stakeholders to monitor and follow-up on deliverables
* Escalating to key stakeholders and mitigating gaps when deliverables are at risk
* Preparing presentations on project status for senior management
* Supporting other activities as needed

What Does A Clinical Project Manager Do At Atricure

* Comprehensive knowledge of ISO (International Organization for Standardization), GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA (Food & Drug Administration) & other applicable regulations governing the conduct of clinical trials
* Broad knowledge and cross-functional understanding of clinical trials methodology
* Thorough understanding of project management tools/techniques
* Responsible for oversight of individual trials as well as relevant clinical program needs
* Oversee the development of key team trial deliverables, such as protocols, informed consent documents, case report forms, trial guidelines and final reports
* Identify, evaluate, & recruit clinical sites
* Oversee contracts & other agreement agreements for all aspects of assigned clinical trials
* Oversee clinical monitoring plan development and oversee monitoring of clinical trials
* Responsible for the conduct of site trial training and investigator meetings
* Provides support to clinical investigator and site coordinators to resolve site-related issues
* Oversee day-to-day project activities of CRAs assigned to specific projects & provide project direction
* Manage escalation of trial related issues and establishes appropriate course of action/mitigation plans
* Participate in trial data review and interpretation
* Serve on various teams & represent clinical as needed
* Participate in departmental developmental initiatives (e.g. training, SOP development, etc

What Does A Clinical Project Manager Do At Beacon Hill Staffing Group-Pharma

* Write and develop clinical protocols, data and tracking forms, informed consent documents, operating procedures, and associated regulatory filings with investigational sites.
* Assists in writing annual and final clinical study reports and clinical sections of regulatory filings.
* Tracks data forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites.
* Works with team to establish study database and edit check requirements.
* Serves as liaison between contracted research organizations, clinical trial sites, investigators, study coordinators, physicians, and staff members.
* Conducts pre-study site qualification and initiation planning and execution including creation of training materials to ensure compliant study execution.
* Assist study sites with IRB/EC submissions and annual reports.
* Oversees delivery and shipment of products and equipment required to conduct clinical investigations.
* Provides technical assistance to study sites regarding the conduct of clinical research.
* Manages clinical sites to optimize the patient recruitment and screening process to reach study recruitment goals.
* Perform co-monitoring visits with CRO staff at participating clinical sites Assists as liaison with Data Management/Biostatistical groups to ensure resolution of data queries.
* Monitors clinical and/or laboratory data to ensure accuracy, thoroughness, and regulatory compliance of clinical documentation.
* Creates study Regulatory and Reference Binders as well as internal trial master file to track all study documents.
* Review, reconcile and maintain Trial Master Files for multi-center, multi-national clinical

What Does A Clinical Project Manager Do At University of Pennsylvania

* Develop clear and measurable project management plans; Define timelines, milestones, and limitations to project staff and study sites
* Monitor project status and timelines
* Manage clinical projects/programs, including deliverables from all functional areas and vendors in accordance with contractual timelines and sponsor specifications
* Establish project metrics and project schedules with client representatives.
* Provide at least monthly project updates
* Facilitate case report form development, review, approval, and finalization with the Data Management Team
* Development of Manual of Procedures (as applicable) and site study binders including all required Sponsor Forms/Templates
* Support clinical development of protocol/consent form documents
* Facilitate local regulatory review committee approvals as required for multisite trials
* Coordinate site initiation visit/site training
* Review/process protocol exceptions/deviations
* Prepare and process DSMB Reports; Organize and coordinate DSMB Meetings
* Reporting of study progress and subject statuses; provide IND summary information for the IND annual report
* Review/report the status of case report form completion and data query resolution
* Develop and provide study and/or protocol amendment training to sites
* Manage/maintain the Sponsor Trial Master Files for each project/site
* Participate in SOP development.
* Qualifications
* Bachelor’s Degree with 5
* years of related experience, or an equivalent combination of education and experience, are required
* Knowledge of FDA regulations and GCP
* ICH guidelines; and comprehensive understanding of clinical trials processes and the conduct of clinical research studies.
* Previous Project Management experience preferred

What Does A Clinical Project Manager Do At SRA International, Inc., A CSRA Company

* Provide clinical trial management support for the Clinical Research Department.
* Set-up, manage and maintain Clinical Trial Master File, all electronic clinical project files in different systems.
* Manage distribution and compilation of reviewed clinical documents (internal or external).
* Contribute to creating, reviewing and compiling assigned clinical documents.
* Manage meeting minutes/agendas for assigned clinical meetings.
* Support training of internal/external collaborators (i.e. may serve as trial trainer of systems, procedures or plans).
* Provide support or back-up in operational aspects of a trial as assigned.
* Participates in department or companywide process improvement initiatives.
* Manage all aspects of DVC managed clinical trials and contracted clinical vendors
* i.e. CRO’s, EDC, IVR, IP, etc.) As assigned.
* Point of contact for all contracted clinical vendors.
* Report a weekly status of each assigned clinical trial to include: performance of vendor’s scope, earned value management (EVM) as applicable, schedule compliance (baseline vs actual), financial/contractual management/reconciliation, deliverables, and overall performance metrics to management (and the project management office as applicable).
* Oversight of CRO’s scoped services (project management, and/or site management, and/or data management and/or monitoring management, and/or biostatistical management) of assigned trial(s) to ensure compliance with ICH GCP and per transfer of regulatory obligations (TORO).
* Serve as the document authority for assigned clinical documents and ensure contractual acceptability/quality of clinical documents created by subcontractors and in-house staff.
* Work with the Medical Director on writing the annual report, Investigators Brochure
* IB), clinical trial protocol, protocol amendments, informed consent forms (ICF), study specific procedures, CSR or clinical reports not outsourced, clinical presentations, and project plans.
* Critically review Monitoring Plans, report and form templates, Data Management
* Plans (eCRF and CRF Guidelines, Edit Specifications), SAP and Analysis
* Specifications, CRO/Vendor procedures, third tier scope/plans and/ other operational plans/documents as applicable for each assigned clinical trial.
* Prepare, review and finalize clinical subcontractor Statements of Work (SOWs) and work with the Subcontracts group on Requests for Proposals (RFPs), Bid negotiations, Task Orders, Change Orders, and Source Selection Team as assigned.
* Work with management to identify, evaluate and select clinical vendors.
* Work with the Medical Director on reporting clinical trial safety reporting.
* Work with the Medical Director on regulatory documents in support of publishing clinical documents for regulatory filing.
* Perform ongoing review of project monitoring status and identifies clinical project risks.
* Implement clinical risk mitigation solutions.
* Participate in delivery assurance/integration reviews with key stakeholders to ensure adherence to contracted client deliverables/milestones, timelines, costs and quality.
* Organize project team members to ensure communication and understanding of deadlines for assigned objectives.
* Manage clinical trial team meetings with subcontractors.
* Manage changes to technical scope requirements, business requirements and schedule changes for the clinical project incorporating stakeholder requirements.
* Provide input to management on possible changes needed based on current project status.
* Work with management to contribute to organizational process assets, best practices and benchmarks

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How To Become A Clinical Project Manager

Natural sciences managers usually advance to management positions after years of employment as scientists. Natural sciences managers typically have a bachelor’s degree, master’s degree, or Ph.D. in a scientific discipline or a related field, such as engineering. Some managers may find it helpful to have an advanced management degree—for example, a Professional Science Master’s (PSM) degree, a Master of Business Administration (MBA), or a Master of Public Administration (MPA).

Education

Natural sciences managers typically begin their careers as scientists; therefore, most have a bachelor’s degree, master’s degree, or Ph.D. in a scientific discipline or a closely related field, such as engineering. Scientific and technical knowledge is essential for managers because they must be able to understand the work of their subordinates and provide technical assistance when needed. 

Natural sciences managers who are interested in acquiring postsecondary education in management should be able to find master’s degree or Ph.D. programs in a natural science that incorporate business management courses. A relatively new type of degree, called the Professional Science Master’s (PSM), blends advanced training in a particular science field with business skills, such as communications and program management, and policy. Those interested in acquiring general management skills may pursue a Master of Business Administration (MBA) or a Master of Public Administration (MPA). Some natural sciences managers will have studied psychology or some other management-related field to enter this occupation.

Sciences managers must continually upgrade their knowledge because of the rapid growth of scientific developments.

Work Experience in a Related Occupation

Natural sciences managers usually advance to management positions after years of employment as scientists. While employed as scientists, they typically are given more responsibility and independence in their work as they gain experience. Eventually, they may lead research teams and have control over the direction and content of projects before being promoted to an administrative position.

Licenses, Certifications, and Registrations

Although certification is not typically required to become a natural sciences manager, many relevant certifications are available. These certifications range from those related to specific scientific areas of study or practice, such as laboratory animal management, to general management topics, such as project management, and are useful to natural sciences managers regardless of the organization being managed.

Important Qualities

Communication skills. Natural sciences managers must be able to communicate clearly to a variety of audiences, such as scientists, policymakers, and the public. Both written and oral communication are important.

Critical-thinking skills. Natural sciences managers must carefully evaluate the work of others. They must determine if their staff’s methods and results are based on sound science.

Interpersonal skills. Natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals. Managers routinely deal with conflict, which they must be able to turn into positive outcomes for their organization.

Leadership skills. Natural sciences managers must be able to organize, direct, and motivate others. They need to identify the strengths and weaknesses of their workers and create an environment in which the workers can succeed.

Problem-solving skills. Natural sciences managers use scientific observation and analysis to find solutions to complex technical questions.

Time-management skills. Natural sciences managers must be able to do multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule.

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Clinical Project Manager jobs

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Real Clinical Project Manager Salaries

Job Title Company Location Start Date Salary
Clinical Project Manager III Inventiv Health Clinical SRE, LLC South San Francisco, CA Jul 14, 2014 $222,560
Clinical Project Manager III Inventiv Health Clinical SRE, LLC Menlo Park, CA Jul 14, 2014 $222,560
Clinical Faculty, PM&R and Palliative Care William Beaumont Hospital Royal Oak, MI Oct 15, 2015 $180,000
Clinical Project Manager Akros Pharma Inc. Princeton, NJ May 27, 2015 $177,258
Clinical Informatics Project Manager Lucile Salter Packard Children's Hospital at Stanf Menlo Park, CA Aug 31, 2014 $160,472
CRD Senior Clinical Project Manager Quintiles, Inc. Durham, NC Nov 22, 2016 $153,566
Clinical Project Manager II Leidos Biomedical Research, Inc. Frederick, MD Aug 07, 2016 $151,133
Associate Director, Clinical Project Manager Pfizer Inc. New York, NY Feb 04, 2011 $146,800
Clinical Project Manager Integrated Resources, Inc. Edison, NJ Aug 31, 2016 $143,250
Clinical Research Project Manager ACRO Service Corp Chesterbrook, PA Sep 11, 2015 $142,480
Clinical Research Project Manager ACRO Service Corporation Wayne, PA Sep 20, 2016 $142,480
Clinical Research Project Manager ACRO Service Corporation Livonia, MI Dec 09, 2016 $142,480
Clinical Research Project Manager ACRO Service Corporation Wayne, PA Dec 09, 2016 $142,480
Clinical Project Manager (CPM) Baxter Healthcare Corporation Cambridge, MA Jan 12, 2015 $118,000
Clinical Project Manager Cardiovascular Research Foundation New York, NY Dec 09, 2016 $115,000
Clinical Trials Project Manager Fred Hutchinson Cancer Research Center Seattle, WA Nov 30, 2015 $114,954
Clinical Project Manager Eastern Virginia Medical School Arlington, VA Jan 12, 2016 $114,905
Clinical Project Manager Eastern Virginia Medical School Arlington, VA Aug 12, 2016 $114,905
Clinical Trials Project Manager Fred Hutchinson Cancer Research Center Seattle, WA Oct 01, 2014 $110,004
Clinical Project Manager Replenish, Inc. Pasadena, CA Aug 25, 2014 $110,000 -
$120,000
Clinical Trials Project Manager Fred Hutchinson Cancer Research Center Seattle, WA May 22, 2015 $109,637
Clinical Project Manager Integrated Resources, Inc. Edison, NJ Nov 09, 2015 $93,915
Clinical Project Manager Integrated Resources, Inc. Edison, NJ Sep 11, 2015 $93,915
Clinical Project Manager Integrated Resources, Inc. Kenilworth, NJ Nov 04, 2009 $93,498
Crimson Clinical Project Manager Methodist Health System Dallas, TX Apr 18, 2014 $92,019
Clinical Database Services Project Manager Accenture LLP Florham Park, NJ Aug 05, 2015 $90,000
Clinical Database Services Project Manager Accenture LLP Lansdale, PA Aug 05, 2015 $90,000
Statistician/Clinical Project Manager Libra Medical, Inc. Brooklyn Park, MN Oct 01, 2013 $90,000

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Top Skills for A Clinical Project Manager

ClinicalTrialsStudyProtocolsRegulatoryDocumentsProceduresClinicalResearchCROProjectManagementSafetyOversightCRAFDAClinicalProjectCRFGCPInvestigatorMeetingsDataManagementIRBPhaseIIIClinicalStudyReportsOncology

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Top Clinical Project Manager Skills

  1. Clinical Trials
  2. Study Protocols
  3. Regulatory Documents
You can check out examples of real life uses of top skills on resumes here:
  • Worked collaboratively with sponsor of clinical trials to speed up enrollment.
  • Generate study protocols, interim reports, and final reports for study sponsors.
  • Participate in the preparation and review of regulatory documents (e.g., safety reports).
  • Provide appropriate guidance to junior personnel to ensure consistent implementation of company monitoring procedures.
  • Established dialogue between the Diabetic Clinical Research Network and Thrombogenics

Top Clinical Project Manager Employers

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