AVP, Clinical Data Management

Job Description

The Associate Vice President, Clinical Data Management, leads the design, execution, and continuous improvement of clinical data management processes in support of our company's global drug and vaccine development portfolio, including acquisitions and external partnerships. -

Reporting to the Head of Global Data Management and Standards, sets the vision for the organization and is responsible for the timely and quality execution of clinical data management services including therapeutic area, program, and study-level planning; risk and issue management; data collection and validation design; user acceptance testing; data validation and discrepancy management; change request management; database lock; and study close-out. -

Additional responsibilities of the Head of Clinical Data Management include:

• Strategic planning and alignment with broader organizational goals and priorities
• Development of strategies to enhance organizational value and efficiency
• Proactive resource forecasting and management to ensure portfolio and other organizational objectives are met
• Leadership of talent development and performance management activities with a focus on building a high-performing team and fostering a culture of growth and development
• Oversight of financial forecasting, budget, and expense management
• Leadership engagement with internal stakeholders and industry leaders to identify opportunities for innovation and continuous improvement
• Ensuring process alignment with regulatory expectations and industry best practice
• Sponsorship and/or leadership of organizational initiatives

Enterprise Leadership Skills - behaviors and impact expected in this role include:

• Strategic Planning: Thinks strategically and gains alignment through collaborative stakeholder engagement and influence across development, clinical operations, regulatory, safety, and IT.
• Execution Excellence: Drives reliable, high - quality delivery by establishing end - to - end processes and KPI - driven measurement approaches (e.g., time - to - lock, query rates, error reduction) to track progress, improve outcomes, and ensure consistent, submission - ready outputs across global and vendor - delivered studies.
• Change Catalyst: Adapts to change and energizes teams through clear, compelling communication at all levels.
• Networking & Partnerships: Proactively builds and sustains strategic internal and external relationships (cross - functional leaders, vendors, alliance partners, customers) to accelerate CDM objectives.

Educational Requirements:

• Required: Bachelor's degree in life sciences, biostatistics, health informatics, or related field
• Preferred: Advanced training or certification in clinical research and/or data management relevant disciplines including, but not limited to: Association of Clinical Research Professional (ACRP) certification; SCDM Clinical Data Manager (CCDM) certification, Project Management Professional (PMP) certification

Required Experience and Skills:

• 15+ years in clinical data management within the pharmaceutical or biotech industry
• 10+ years in progressive leadership roles managing clinical data management functions
• 10+ years of experience and demonstrated success in personnel management, including direct line management of managers in a matrixed, global organization
• 7+ years proven track record managing vendor delivery and partnerships (ex. FSPs, CROs, central labs, eCOA/ePRO, IWRS/IVRS, imaging)
• Experience leading clinical data management delivery and services across therapeutic areas and development phases, including registrational and post-marketing studies
• Experience using and/or managing data management and clinical trial technologies including EDC, encoding utilities, CTMS, eTMF, IVRS/IWRS, ePRO/eCOA, eSource, clinical data warehouses, and data reporting, visualization, and analytics platforms
• Experience using and/or managing data standards (CDISC - SDTM/ADaM, CDASH) and submissions-ready data deliverables for regulatory agencies (FDA/EMA/PMDA).
• Knowledge of full CDM lifecycle: data collection and validation design, data capture, data cleaning and reconciliation, database lock, and study close out
• Familiarity with regulatory expectations for electronic data, eSource, and data integrity (ICH E6 R3, 21 CFR Part 11)
• Working knowledge of risk-based monitoring and data cleaning strategies
• Strong analytical and problem-solving ability with a pragmatic approach to balancing timelines, quality, and cost
• High integrity and a compliance-focused mindset
• Ability to convert complex technical concepts into clear, concise, and actionable communications for non-technical executives and cross-functional stakeholders.
• Outstanding written and verbal communication skills that can be deployed across all levels of the organization

Required Skills:
Accountability, Accountability, Building Leadership Teams, Client Management, Clinical Data, Clinical Data Management, Clinical Information Systems, Clinical Quality Management, Clinical Study Management, Clinical Study Protocols, Clinical Trials, Conflict Resolution, Customer-Focused, Data Processing, Detail-Oriented, Documentations, Ethical Standards, Financial Forecasting, Good Clinical Practice (GCP), High Performance Team Building, Innovation, Management Process, Mergers and Acquisitions (M&A), Organizational Performance Management, People Leadership {+ 5 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$282,200.00 - $444,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

Employee Status:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
03/17/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R387333