Data Management Trial Manager

**Job Description**:
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

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, Merck clinical data management procedures. Interacts with staff across multiple Merck 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.
- 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.
- 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.

Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials, as assigned

Supports site and sponsor audits, as appropriate

Identifies and supports improvements to data collection and data management processes and tools.

ONEGDMS

Position Qualifications**:
**Education**: B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.

**Experience**: At least 3 years’ experience in Clinical Data Management

**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.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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.

**What we look for**

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, col