Trial Manager (PDMS)
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Oversees the data management strategy and project plans for collection and integration of all clinical data including but not limited to , case report forms (CRF) data, lab data, biomarker data, and patient reported outcomes for one or more trials within a specific drug program. Works with a cross-functional team across multiple sites to ensure that all aspects of the project plan (from protocol planning through data management submission components) are executed on time and with appropriate quality. 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.
- 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 decomissioning of clinical data management technologies.
- B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
- At least 3 years' of Clinical Data Management Experience;
- Full life-cycle experience in clinical data management (data collection system development through database lock and close-out and submissions;
- At least 1 year experience working with formal project management tools (MS Project) and processes.
- 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 clinical data.
- Strong organization and management skills.
- Must be able to communicate effectively both orally and in written form with technical and business areas.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. If you need an accommodation for the application process please email us at email@example.com.
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Job: Clinical Data Management
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck