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Become A Clinical Trial Manager

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Working As A Clinical Trial 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

  • $68,391

    Average Salary

What Does A Clinical Trial Manager Do At Abbvie

* Study Planning and Conduct:
* Responsible for all operational aspects and progress of clinical trial from a study planning activities to study execution including ongoing tracking all applicable performance metrics and quality indicators
* Serves as an escalation point and resource for internal/external teams and investigational sites; partners with cross functional groups to achieve deliverables
* Oversees/facilitates country and site feasibility/selection processes
* Develops/oversees subject recruitment/retention strategy and related initiatives
* Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR) development, etc.
* Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate.
* Responsible for and participates in clinical service provider (vendor) selection process as a part of outsourcing activities.
* Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations)
* Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and vendors
* Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
* Ensures that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct
* Conducts Sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as needed
* Project Management:
* Creates, manages, measures, and reports timelines for milestone deliverables
* Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders
* Prepares metrics and updates for management
* Oversees internal team meetings, investigator meetings, and other trial­ specific meetings
* Participates in the development, review, and implementation of departmental SOPs, WIs, initiatives and processes
* May manage/mentor direct reports and team members, and perform performance appraisals as assigned
* Financial Planning and Management:
* Strong understanding of the cost drivers and are accountable for the development, management, reconciliation of overall study budget(s) and resource allocation
* Collaborates in the development/management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines
* Reviews/approves vendor invoices and manages accruals and payment process for all clinical trial vendors including investigative sites
* Maintains completion of required corporate training on standards, policies, work instructions by due date
* Perform other work related duties as assigned

What Does A Clinical Trial Manager Do At Endo International

* Lead and manage cross-functional team to the achievement of clinical trial goals.
* Proactively identify project risks and develop plans to mitigate them.
* Contribute to data management and statistical analysis plans, ensuring clinical trial objectives are aligned with the delivery of evaluable data.
* Ensure operational excellence and integrity through adherence with Endo policies and procedures, GCP, ICH, FDA and all other international regulatory requirements.
* Monitor and manage the clinical trial budget across all functional areas.
* Review and approve invoices from sites and providers to ensure accurate,and timely payment.
* Partner with outsourcing on vendor selection, operational, assessments, contract management and invoice approval.
* Drive site selection and patient recruitment programs that deliver enrollment targets.
* Establish a visible Endo profile with investigator sites during study start up and ensure site-to-sponsor communication is effective and efficient through the trial.
* Manage and coordinate with external service providers including clinical research organizations (CROs), EDC platform providers, laboratories and others, serving as primary point of contact, preparing scopes of work, ensuring agreed deliverables are achieved on time and monitoring key performance indicators.
* Provide formal oversight and ensure inspection-ready documentation exists for sponsor obligations transferred to CROs and other providers.
* Review monitoring reports and perform co-monitoring visits.
* Train and supervise staff assigned to clinical trial projects.
* Ensure operational aspects of the clinical trial are satisfactorily addressed early in protocol development.
* Establish timelines and budget.
* Contribute to the development of clinical study reports.
* Provide support for presentations and publications

What Does A Clinical Trial Manager Do At United Therapeutics

* Provides comprehensive oversight of operational aspects of assigned clinical trials
* Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance during clinical trial conduct
* Serves as a liaison and resource for investigational sites
* Assists with investigator contracts and site payments
* Develops and contributes to study related documents, including protocols, case report forms, site study manuals, project tools, monitoring plans, tracking tools and informed consent forms
* Organizes and manages clinical operations internal CRA team meetings and other trial-specific meetings as appropriate
* Serves as direct manager to CRAs and assists with management of study-specific CROs and vendors as appropriate
* Performs occasional co-monitoring of sites as appropriate
* Attends site initiation visits or site motivational visits when appropriate
* Adds insight regarding evaluation and selection of CROs, contractors and other outside vendors as needed
* Manages study start-up efforts, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operations staff and other departments
* Presents study/project metrics to upper management as needed
* Works with Contracts on vendor and study site budget development, scope of work revisions, tracking and compliance
* Uses well-developed problem-solving skills to address needs of program and may provide guidance to other lower level personnel
* Assist the Department Head with overall study management, including internal budget and contract management and forecasting

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

* Support the lead Clinical Trial Manager in the planning, execution and control of one or more clinical trials.
* Create site questionnaires, review completed site questionnaires and qualification visit reports, and coordinate the site approval process.
* Coordinate with the cross-functional team to ensure site confidentiality agreements and clinical trial agreements are executed.
* Create study specific informed consent forms, and lead the review and approval process.
* Support investigators in fulfilling their obligations with regard to submission and maintenance of trial documents according to applicable local, regulatory and IRB/IEC requirements.
* Oversee the essential document collection process, including review and approval in support of drug shipment to study sites.
* Coordinate translation of selected study documents.
* Contribute to review and finalization of key study plans and site facing documents.
* Troubleshoot, advise and follow up trial progress with investigative site staff and clinical vendors.
* Monitor clinical vendors for quality of service.
* Manage subject screening/enrollment, data collection and query resolution and trial supplies at investigative sites.
* Manage distribution of study supplies to clinical sites Perform and/or oversee data entry into CTMS, project timeline, or other project management systems as needed.
* Assist with the preparation, coordination and documentation of the study team meetings.
* Prepare key reports and documents on progress of trial and quality issues/concerns for the project team in a timely manner.
* Address study site issues/concerns with the investigator and other study team members as needed, determine root cause, and independently offer corrective and preventative actions, documenting follow-up activities and outcomes Draft and coordinate approval of clinicaltrials.gov listings.
* Prepare site newsletters and other communications.
* Review clinical data listings and participate in data review processes.
* Train team members on project specific tasks as applicable.
* In-house monitoring of study site activities and data collection.
* Site management, which may include; pre-study visits, initiation visits, monitoring visits, telephone contacts and study close-out visits and/or visit report review.
* Monitoring visit activities include, but are not limited to: source document review; CRF review and data corrections; review of patient consent process; drug accountability; review of investigative site files; and Serious Adverse Event (SAE) reporting according to the protocol/project specifications Participate in company required and/or sponsored training programs and initiatives.
* Perform other duties as assigned

What Does A Clinical Trial Manager Do At Advanced Clinical

Leading aspects of one or more trials or regions Managing clinical study teams to ensure trials are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines to meet corporate objectives Providing oversight and cross-functional team leadership in the management of study(ies) Leading and managing oversight of the CROs and other study vendors Leading clinical operations personnel, including in-house and contract CRAs Contributing to key document preparation and review (protocols, IBs, CSRs, NDA/BLA, etc) Managing, mentoring and developing junior staff

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How To Become A Clinical Trial 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 Trial Manager jobs

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Clinical Trial Manager Demographics

Gender

  • Female

    65.9%
  • Male

    31.2%
  • Unknown

    2.9%

Ethnicity

  • White

    76.0%
  • Asian

    11.2%
  • Hispanic or Latino

    9.4%
  • Unknown

    2.7%
  • Black or African American

    0.7%
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Languages Spoken

  • Spanish

    38.5%
  • German

    11.5%
  • French

    11.5%
  • Japanese

    7.7%
  • Irish

    3.8%
  • Chinese

    3.8%
  • Cantonese

    3.8%
  • Norwegian

    3.8%
  • Persian

    3.8%
  • Mandarin

    3.8%
  • Polish

    3.8%
  • Arabic

    3.8%
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Clinical Trial Manager

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Real Clinical Trial Manager Salaries

Job Title Company Location Start Date Salary
Clinical Trial Manager Integrated Resources, Inc. Edison, NJ Jun 01, 2016 $174,450
Clinical Trials Manager Immunexpress Inc. Seattle, WA Jan 01, 2016 $164,000
Clinical Trials Manager Immunexpress Inc. Seattle, WA Jan 01, 2014 $162,469
Senior Clinical Trial Manager Alnylam Pharmaceuticals, Inc. Cambridge, MA Mar 14, 2016 $135,000
Senior Clinical Trials Manager Genentech, Inc. South San Francisco, CA Mar 20, 2014 $132,015
Clinical Trial Manager III Genentech, Inc. South San Francisco, CA Jun 11, 2012 $130,000
Senior Clinical Trials Manager Gilead Sciences, Inc. Foster City, CA Jun 25, 2016 $129,900 -
$137,000
SR. Clinical Trials Manager Gilead Sciences, Inc. Foster City, CA Nov 22, 2016 $129,072
Clinical Trial Conduct Manager West Coast Clinical Trials, LLC Cypress, CA Jul 10, 2015 $128,066
SR. Clinical Trials Manager Gilead Sciences, Inc. Foster City, CA Sep 29, 2016 $126,222
SR. Clinical Trials Manager Peregrine Pharmaceuticals, Inc. Tustin, CA Jun 13, 2011 $125,000
Clinical Trials Manager Perrigo New York, Inc. New York, NY Jul 25, 2016 $125,000
Clinical Trial Manager Merrimack Pharmaceuticals, Inc. Cambridge, MA Jul 26, 2016 $110,619
Regional Clinical Trial Manager Icon Clinical Research LLC New York, NY Nov 11, 2016 $110,395
Clinical Trial Manager Turing Pharmaceuticals LLC New York, NY Aug 10, 2015 $110,000 -
$130,000
Clinical Trial Manager Novartis Vaccines and Diagnostics, Inc. Harrison, NJ Aug 12, 2013 $110,000
Clinical Trial Manager Novartis Vaccines and Diagnostics, Inc. Chicago, IL Jun 17, 2013 $107,000
Senior Clinical Trial Manager Glaxosmithkline LLC Chicago, IL Mar 12, 2015 $107,000 -
$148,300
Senior Clinical Trial Manager Merrimack Pharmaceuticals, Inc. Cambridge, MA May 01, 2012 $107,000
Manager, Clinical Trials Medstar Health Research Institute Washington, DC May 02, 2014 $91,229
Clinical Trials Manager RENU Laboratories, Inc. Doral, FL Sep 20, 2013 $90,000
Clinical Trials Manager Skin Sciences, Inc. Doral, FL Mar 15, 2015 $90,000
Clinical Trials Manager Skin Sciences, Inc. Doral, FL Nov 01, 2014 $90,000
Clinical Trials Manager RENU Laboratories, Inc. Doral, FL Sep 05, 2013 $90,000
Clinical Trial Manager Merrimack Pharmaceuticals, Inc. Cambridge, MA Jun 08, 2015 $88,000 -
$95,455
Clinical Trial Manager Glaxosmithkline LLC Harrison, NJ Mar 12, 2015 $87,000 -
$148,300
Senior Clinical Trial Manager Takeda Global Research & Development Center Inc. Deerfield, IL Jul 01, 2010 $87,000 -
$126,000

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Top Skills for A Clinical Trial Manager

ProtocolDevelopmentRegulatoryDocumentsCROCrasIDEClinicalResearchClinicalStudyReportsProceduresInvestigatorMeetingsSafetyFDACRFIRBOncologyPhaseIIIClinicalOperationsInitiativesDataManagementProjectManagementSiteSelectionStudyProtocol

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Top Clinical Trial Manager Skills

  1. Protocol Development
  2. Regulatory Documents
  3. CRO
You can check out examples of real life uses of top skills on resumes here:
  • Provide input regarding protocol development and subsequent amendments.
  • Provide oversight and management of regulatory documents.
  • Managed multiple clinical trial budgets of 12+ million across all functional areas.
  • Review monitoring visit reports, may accompany CRAs to on site visits.
  • Identified issues that may have impacted overall project plan and initiated contingency plans.

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