Merck Associate Director, GCDS TA Lead in Boston, Massachusetts

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.

The GCDS TA Lead is a subject matter expert who provides clinical data standards expertise (e.g., CDISC standards) as it relates to developing clinical data collection tools and SDTM mapping.

  • Provide recommendations to the CRF design and database structure to ensure sufficient alignment of standards between data collection, analysis & reporting, and submission deliverables.

  • Develops eCRF specifications for new/updated eCRFs to meet therapeutic area, industry and regulatory standards requirements including SDTM mapping and CDISC controlled terminology

  • Develops eCRF Development Instructions and maintains standard T&E Ensures the completion of all standards components

  • The GCDS TA Lead may be responsible for coordinating data processes related to new therapeutic areas, which may require creating standards from scratch rather than updating or changing existing standards.

  • Support department initiatives and participate in data governance reviews and projects. Chair Therapy Area Standards Team (TAST)

  • Lead/participate in departmental or cross-functional working groups and process improvement activities.

  • Represents function in cross-functional project teams; establishes collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company.

  • Maintain knowledge of new technologies, industry standards, regulatory requirements, and Merck guidelines and SOPs.

  • Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple Merck sites. Mentors, guides, and provides project leadership for junior staff as assigned.

  • May support any other project or perform any other data management task deemed appropriate by management.

Education:

  • Required: B.A. or B.S. degree

  • Preferred: Degree concentration in life sciences, computer science or related field.

Required:

  • At least 8 years work experience which includes 4 years of data management experience and a minimum of 2 years clinical data standards development; or advanced degree with 6 years work experience of which 2 years need to be in clinical data stadnards development

  • Advanced knowledge and leading-edge skills in clinical data standards (e.g., CDISC) CDISC Study Data Tabulation Model (SDTM) expertise

  • Electronic Data Capture expertise (e.g., InForm)

  • Analysis and Reporting experience

  • A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements.

  • Knowledge of the Drug Discovery Process, ICH and GCP guidelines

  • Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business areas

  • Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects.

Preferred:

  • Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.

  • Knowledge of and direct experience implementing industry standards (e.g. Controlled Terminologies, CDISC CDASH, SDTM, ADaM, & HL7) and requirements for submission deliverables (e.g., SDRG, ADRG, Define.xml)

  • Experience implementing Oncology data standards

\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 staffingaadar@merck.com.

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Job Clinical Data Management

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Other Locations: NA-US-PA-Upper Gwynedd, NA-US-MA-Boston

Title: Associate Director, GCDS TA Lead

Primary Location: NA-US-NJ-Rahway

Requisition ID: CLI006107