2019 MRL Project Data Management Services Trial Manager Intern

Requisition ID: ADM009844

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. Candidate will serve 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.  
  • 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 decommissioning of clinical data management technologies. 

This is a full- time internship position. Housing subsidy is not available as part of this program and must be funded 100% by the student.

Qualifications

Education:
  • Required: Candidates must be currently enrolled in a minimum of a B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.
Required Experience and Skills:
  • Candidates must be available to work full-time for up to (12) consecutive weeks in May or June of 2019.
  • Candidates must have at least (3) years' of Clinical Data Management Experience
  • Candidates must have full life-cycle experience in clinical data management (data collection system development through database lock and close-out and submissions
  • Candidates must have at least (1) year experience working with formal project management tools (MS Project) and processes. 
Preferred Experience and Skills:
  • Candidates should have an understanding of the clinical research process and some basic Clinical Data Management lifecycle knowledge is preferred.
  • Candidates should be familiar and comfortable with database concepts and tools to manage, extract, and report clinical data is preferred.
  • Candidates should have strong organization and management skills.
  • Candidates should 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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected]

  

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:

 

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 Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.
FTP2019 FTPMRL2019

Job: Administrative Svcs Generic
Other Locations: Rahway, NJ, US
Employee Status: Temporary
Travel: No
Number of Openings: 2
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Company
Merck
Posted
09/06/2018
Type
Full time
Location
West Point, PA 19486, US