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.
Provides functional area leadership and direction to direct reports and/or supervised staff for business deliverables assigned. Determines, collects, interprets, and actions performance metrics.
Sets priorities and develops challenging but achievable performance objectives for staff that is closely aligned to broader organizational goals; makes work assignments; and ensures the staff
receives appropriate and necessary training.
Motivates staff and maximizes their effectiveness by ensuring realistic workload; estimating length and difficulty of tasks and projects; anticipating and adjusting for obstacles; and elevating complex issues to the appropriate level of management.
Conducts periodic assessment of staff performance; provides feedback and coaches for performance; conducts formal annual performance appraisals for direct reports; and provides rewards and recognition.
Works with direct reports in the establishment of career development plans and to provide opportunities for growth and development. Contributes to organizational succession plans and prepares promotion recommendations.
May facilitate or participate in the recruitment and hiring of staff; may supervise contingent, non-
exempt, or temporary workers (on-shore and/or offshore).
Increases functional area effectiveness by conducting management and functional area meetings; supports efforts to enhance procedures, share best practices, and/or lead continuous improvement efforts; contributes expertise through formal or informal presentations. May be responsible for the development of Standard Operating Procedures.
Keeps abreast of process, technology, and regulatory changes within and outside of Merck; may contribute to, or be responsible for, the development of Standard Operating Procedures.Qualifications
- Bachelor’s degree
- Preferred: At least B.A. or B.S. degree, preferably in life-sciences, computer science, pharmacy, or other health care related discipline.
- Minimum 6 or more years’ experience in Clinical Data Management or related industry experience (technology and/or system development background preferred)
- Minimum 3 or more years of supervisory or management experience
- In depth knowledge of the clinical data management and system development lifecycle, including tools used to collect, manage, extract, and report data including:
- 2 or more years’ experience in at least one of the following: CDISC Standards (SDTM, CDASH, Define.xml), SQL, PL-SQL, XML, Java, ELT tools, Data Management Warehouse (DMW) or similar Clinical Data Management System.
- 2 or more years' experience with the migration of outsourced or third-party trials to a common structure for use in submissions
- 1or more years’ experience with oversight and project management of migration activities
- 2 or more years’ experience with delivery of data flow to a repository or warehouse
- Strong organizational leadership ability and experience in positively and successfully leading in a team environment
- Highly organized with strong time management, negotiation, problem solving, and project coordination skills; can work independently and effectively adapt in a high-paced environment
- Exceptional communication skills (oral and written) with the ability to establish and maintain effective working relationships at all levels of an organization, including both technical and business areas
- In depth knowledge of drug discovery process, FDA regulations (including 21 CFR Part 11), GxP, and ICH guidelines.
- Minimum 6 years’ experience in Clinical Data Management or related industry experience (technology and/or system development background preferred)
- Minimum 3 years of supervisory or management experience
- In depth knowledge of systems related to data management (e.g, InForm, DMW, Metadata Management, ETL Tools, LSH) including:
- Minimum of 2 years’ experience in at least one of the following: CDISC Standards (SDTM, CDASH, Define.xml), Data Management Warehouse (DMW) or similar Clinical Data Management System.
- Minimum of 2 years’ experience with the migration of outsourced or third-party trials to a common structure for use in submissions
- Minimum of 1 year of experience with oversight and project management of migration activities
- Minimum of 1 years of experience with delivery of data flow to a repository or warehouse
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.
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Job: Clinical Data Management
Employee Status: Regular
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Company Trade Name: Merck