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Job Details

Clinical Data Management Early Development Project Data Manager EDEV PDM

Location
Rahway, NJ

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Profile

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.
The EDEV Project Data Manager (EDEV PDM) creates and ensures the successful execution of the early development clinical data management strategy for one or more drug/vaccine/biologic program(s). Develops and manages project plans which span from protocol development through data management submission components. Ensures all aspects of the project plan are executed on time and with appropriate quality. May serve as the lead PDM or perform a support role for filing programs. Participates in the development of, and ensures adherence to, our organization’s clinical and regulatory data management standards. Interacts with staff across different sites, countries, and time zones.
Qualifications
Education Minimum Requirement:
B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
Required Experience and Skills:
At least 6 years’ experience in Clinical Data Management with at least 3 years’ experience working with formal project management tools and processes.
Preferred Experience and Skills:
Understanding of the clinical drug development process, focus on early phase/translational medicine, with in-depth knowledge of the Clinical Data Management lifecycle.
Familiar and comfortable with database concepts and tools to manage, extract, and report data.
Demonstrated excellence in complex project management and effectively managing multiple projects/priorities.
Strong organizational and problem-solving skills.
Ability to communicate (written and oral) effectively with technical and business areas.
Ability to effectively work across boundaries, applying understanding of cultural differences to communication and collaboration practices.
Experience with MS Project.
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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to
****
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.
Job:
Clinical Data Management
Other Locations:
West Point, PA, US
Employee Status:
Regular
Travel:
Yes, 5 % of the Time
Number of Openings:
1
Shift (if applicable):
Hazardous Materials:
No
Company Trade Name:
Merck
Nearest Major Market:
New York City
Nearest Secondary Market:
Newark

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