Associate PDMS Trial Manager

Merck - West Point, PA (30+ days ago)4.1


Requisition ID: CLI007452

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 Associate Trial Manager assists in ensuring the successful execution of the clinical trial data management strategy for assigned trials within a specific drug / vaccine program. Assists in start-up activities, database maintenance, and database finalization for each trial. Attends Study Team meetings and works in a team environment. Assists in developing and managing project plans which span from protocol development through database lock. Ensures all aspects of the project plan are executed on time and with appropriate quality.

Primary Activities:
Under the guidance / supervision of more senior staff assumes the following responsibilities:

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.
Supports the project management of all clinical data management activities with incremental responsibilities for trials as assigned, using excellent interpersonal, negotiation, and project management skills to assist with the following tasks:
Project planning, initiation, execution, change control, and closing.
Risk management identification.
Meeting customer / stakeholder expectations.
Meets 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 assists in processing of standards and change requests.
Participates and 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.

Qualifications

Education:
B.A. or B.S. Degree, preferably in Life Sciences, Computer Science, or related discipline.

Required Experience and Skills:
At least 2+ years’ experience in data management, medical research, or database design and development additional experience in project management tools and process would be beneficial.
Good basic awareness of the clinical research development process. Familiar with database concepts and tools.

Preferred Experience and Skills:
Proven leadership skills, specifically the ability to coordinate the work of others. Good sense and awareness of regulations and policies. Must be able to communicate effectively — orally and in written form — with other stakeholders
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 staffingaadar@merck.com.

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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.

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Job: Clinical Data Management
Other Locations: Rahway, NJ, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name: Merck