Executive Director, Global Data Operations:
Merck

CLI007012-en_US
Merck
West Point Pennsylvania
Pharmaceutical
Description
Requisition ID: CLI007012

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. 

 

Primary activities include, but are not limited to:
Directs all data management support activities as it relates to Global Data Operations responsibilities. This may include responsibility for clinical research, clinical pharmacology, and epidemiology studies as well as non-project support.
1. The Executive Director of Global Data Operations is responsible for the development, implementation, oversight, and maintenance of the Global Data Operations (GDO) operations.
2. Ensures that all CDM products and services are effectively delivered to meet MRL ESD/LSD Book of Business (BOB) planning commitments
3. CDM Deliverables include but not limited to EDC systems, edit checks, data review plans, all data integrity/quality review activities, patient reported outcomes (PRO and ePRO), device/laboratory external data integration, IVRS services, 3rd party data integration and interim/final database locks.
4. Aligns others around a positive direction. Under the guidance of the department head and/or their manager, develops high level, challenging, but achievable objectives that clearly support stated organizational goals. Forecasts short and long term resource needs, establishes measures to improve their area’s effectiveness and efficiency, and develops strategic plans.
5. Develops career plans for direct reports (some of whom may be at the Manager/Associate Manager level), makes work assignments, conducts periodic skill assessments as well as annual performance appraisals, coaches for performance, provides on-going feedback on performance, provides rewards and recognition, and sets priorities.
6. Provides developmental opportunities for employees, through management team or directly, including challenging growth assignments. Develops promotion strategies for their area. Ensures employees receive appropriate training and mentoring to be successful in their assignments.
7. Provides advice and consultation on data management or functional area-specific activities to both internal (e.g., Clinical, Regulatory Affairs, BARDS, Human Resources, etc.) and external (e.g., clinical investigators, regulatory agencies, vendors, etc.) clients.
8. Directs and leads global Data Management Operations and Facilities and the deliverables of those facilities.
9. May play a lead role in customer engagement, cooperation and management at the most senior levels
10. Develops and leads strategic change projects on behalf of GDMS.
11. Directs staff in the development, implementation, and documentation of standard operating procedures (SOPs) related to their area’s functions to ensure compliance with worldwide regulatory and relevant internal Merck requirements.
12. May play a key role in the selection of in-house and external data management systems and the determination of work processes.
13. May collaborate with data management groups from other divisions, companies, and agencies to ensure the validity and effectiveness of data management techniques and processes within GDMS
14. Keeps abreast of new developments in the area of clinical data collection, processing, storage, and retrieval in order to provide guidance in the selection, enhancement, and maintenance of data management tools and processes.
15. May sponsor or provide direction to a continuous improvement special project.
16. May support any other project or perform any other data management task deemed appropriate by management.
17. Serves as a member of the GDMS Senior Leadership Team, which is responsible for decisions affecting all GDMS, and acts as a representative on appropriate MRL and Merck committees.
18. Sets and communicates the department’s vision. Supports overall GDMS objectives and ensures staff are equipped to achieve success in terms of cycle time metrics, retention rates, and productivity improvements
19. Under the general guidance of the Head of GDMS, manages the departmental budget to ensure optimal allocation of resources. Requests and justifies deviation from the budget when appropriate.

Qualifications

Education:

  • At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, Health Care, Computer Science or Engineering related discipline.

Experience:

  • Minimum 10 years’ experience in Clinical Operations and/or Clinical Data Management (or related industry experience) including at experience in a management position
  • Experience and demonstrated ability to manage a large (>300), global and diverse organization that has flexible staff and 3rd party partners.
  • Experience leading an organization that delivers against pre-established and benchmarked service level standards (quality, timeliness and productivity) for all deliverables and services.
  • Experience working with internal (Clinical Sciences, BARDS, GCTO, MRL IT) and external (functional service providers, labs, investigator sites, etc.) stakeholders to deliver products and services to support a portfolio of clinical trials/programs across multiple therapeutic areas.
  • Experience leading/sponsoring process and/or technology based innovation initiatives to maximize delivery of services with measurable outcomes.
  • Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines.
  • A broad comprehensive knowledge of the clinical trial process including data management (data collection, validation, processing, storage, and retrieval), Merck products, and worldwide regulatory data management and reporting requirements.
  • Exceptional communication skills (oral and written), with the ability to communicate with both

     

 

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.

  

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 



Job: Clinical Data Management
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement