Job Description

The Program Manager oversees the projects and or activities within Global Clinical Data Standards purview and the associated clinical information governance network in collaboration with the Director of Operations, Global Clinical Data Standards. They monitor, track, and control outcomes to resolve issues, conflicts, dependencies, and critical path deliverables using a consistent project management methodology. Through teamwork and a data driven approach, they would work analytically and creatively to solve problems. Coordinates our Company’s standards governance network and facilitates our Company participating in and connecting with external standards related activities (e.g., CDISC, PhUSE, TransCelerate). Manages the definition, implementation, and maintenance of GCDS Standard Operating Procedures and supporting documentation to ensure compliance with worldwide regulatory and relevant internal requirements of our Company.

Primary activities include, but are not limited to:

• Ensure individual projects are completed on time, within budget, and in alignment with company goals.

  • Projects will have set timeframes.

• Prepare and manage project materials.

  • Including a project plan, RACI, meeting materials (e.g., notes, decision log, action items, etc.), timeline, kick-offs, retrospective reviews .

• Establish appropriate metrics to track and monitor progress and quality (as necessary).

• Bring together team members.

• Communication with and motivation of stakeholders.

• Addressing pain points, risks, and maintaining quality control.

• Prepare and maintain project status reports.

• Ability to organize and run meetings efficiently.

• Ability to show critical thinking and a “think-on-your-feet” mindset.

• Lead/participate in cross-functional data governance reviews and projects.

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

• 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, clinical information industry standards, regulatory requirements, and our Company's guidelines and SOPs.

• Define and oversee implementation of a standards communication plan.

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

Education Requirement

• Bachelors of Arts or Sciences and minimum of 8 years’ experience in Program Management of which 3 years needs to be in clinical research, data management, or metadata management (or related discipline), demonstrate deep SME (Subject Matter Expert) skill in relevant discipline.

OR

• Advanced Degree (master's or doctorate) and minimum of 4 year’s experience in Program Management of which 3 years needs to be in clinical research, data management, or metadata management (or related discipline), demonstrate deep SME skill in relevant discipline. ​

Experience

• Broad knowledge of and experience with clinical development & data management processes and regulatory requirements

• Extensive program and/or project management experience managing and governing clinical information standards activities.

• Awareness of industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (SDRG, ADRG, Define.xml).

• Must have awareness of project management methodologies (e.g., Scrum, Agile, Waterfall) and tool.

• Experience in defining, implementing, and managing process improvement projects and documentation.

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

• Exceptional verbal and written communication skills in a global environment, with the ability to communicate with both the technical and business stakeholders

• Exceptional people and thought leadership skills, with the ability to think strategically, influence others and work collaboratively with cross-functional stakeholders.

Required Expertise and Skills

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

• Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines

• Proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initiative and motivation. Proven ability to solve complex problems.

• Strong skills in project management

• Ability to effectively organize and manage multiple assignments with challenging timelines.

• Ability to mentor cross functional colleagues in data standards and metadata management practices.

• Knowledge and Skills Desirable but not Essential

• Direct experience implementing industry standards.

• In-depth knowledge in industry data standards, regulatory data submission requirements, and demonstrated experience in the development and implementation of standard methodology.

• Knowledge of clinical data management systems (e.g., Inform, Rave).

• Knowledge of SAS and statistical methodologies.

• Ability to leverage technical solutions to manage deliverables and associated quality with assigned projects.

• Ability to use programming and other applications to generate insights from data.

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Required Skills:

Accountability, Adaptability, Clinical Database Programming, Clinical Data Management, Clinical Data Standards, Clinical Trials, Data Analysis, Data Governance, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), International Regulatory Compliance, Interpersonal Relationships, Leadership, Mentoring Staff, Metadata Management, Process Improvement Projects, Project Management

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

$142,400.00 - $224,100.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

04/8/2026

*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.