PDMS Program Manager Job - United States
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 125-year legacy. 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 form (CRF) data, lab data, biomarker data, and patient reported outcomes for one or more development programs. 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. Partners with functional area representatives to ensure appropriate use of database standards and project-level consistency on database, data collection, review, and retrieval specifications.
Serves as project manager of all clinical data management activities for protocols and/or compounds as assigned. Uses excellent interpersonal, negotiating, and project management skills to perform the following tasks:
- Project plan development, execution, and change control
- Project team development, resource planning, and cost estimating
- Risk management
- Communications planning, information distribution, performance reporting, and project closure
Provides direction for integrating external teams into the data management processes and ensures that data from disparate sources and database structures align with the clinical data management strategy.
Participates in the development of, and ensures adherence to, Merck clinical and regulatory data management standards.
Mentors, guides, and provides project leadership for junior staff as assigned.
Keeps abreast of project and clinical data management disciplines through interaction with experts both within and outside of the company.
May lead continuous improvement special projects, or perform any other data management tasks deemed appropriate by management.
- Bachelor's degree, preferably in life sciences, computer science, or related discipline.
- At least 6 years’ experience in Clinical Data Management;
- Full life-cycle experience in clinical data management (data collection system development through database lock and close-out);
- At least 3 years’ experience working with project management tools and processes;
- At least 2 years' experience/exposure working in Oncology Therapeutic Area.
- Knowledge of the clinical development process with in-depth knowledge of the Clinical Data Management lifecycle through submission deliverables.
- Able to work independently and as a member of team with equal effectiveness. 3. Demonstrated team leadership and project management skills.
- Proven strong organizational and problem-solving skills.
- Proven effective communication skills both orally and written with both 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 firstname.lastname@example.org.
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Job: Clinical Data Management
Job Title:Assoc. Dir, Clinical Data Mgmt
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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