Project Data Management Services Trial Manager

Job Description

The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock. Collaborates with appropriate functional areas to align resources and ensure all aspects of the project plan are executed on time and with appropriate quality. Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity and requirements. Manages change, customer and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents Global Data Management on cross-functional trial teams and in other trial-level development forums.

Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs. Participates in the development of, and ensures adherence to, our Company's clinical data management procedures. Interacts with staff across our Company's multiple sites.

Primary Activities:

Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine program. Data includes, but is not limited to, case report form (CRF) data, lab data, biomarker data, and patient reported outcomes. Serves as project manager of all clinical data management activities for trials as assigned. Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the following tasks:

• Project planning, initiation, execution, change control, and closing.

• Project team development, project team leadership, meeting management, and resource coordination.

• Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.

• Management of customer / stakeholder expectations; facilitation of cross-functional decisions.

Defines trial-level requirements for quality data collection and validation at the trial level.

• Reads and interprets the clinical protocol from a clinical data management perspective.

• Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility.

• Engages with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs (including timing), and confirm all data management deliverables and services required for a trial.

• Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation.

• Facilitates assessment and processing of standards and change requests.

• Approves trial-level data validation plan (including project and protocol specific data validation elements).

Manages trial-level data quality and completion of database lock and post-database lock activities:

• Monitors overall status and quality of data being collected during the in-life portion of a trial.

• Engages with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.

• Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.

• Ensures timely archival of trial data and documentation.

• Ensures timely decommissioning of clinical data management technologies.

Knowledge and Skills:

• Understanding of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle.

• Familiar and comfortable with database concepts and tools to manage, extract, and report data.

• Strong organization and management skills.

• Must be able to communicate effectively — orally and in written form — with technical and business areas.

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We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Expected salary range:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Relocation:

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Requisition ID:R242689