Job Description

This role is accountable for the execution and oversight of local operational start up clinical trial activities in compliance with ICH/GCP and US regulations. This position will have end to end accountability of US Site and Study Start Up as well as develop new, innovative strategies and approaches for site validation and engagement (including site scouting). This role will create new ways of working to support territory development to ensure the efficient, timely, and compliant start-up of clinical studies, collaborating closely with cross-functional teams to accelerate clinical development and advance our company's mission of improving patient outcomes. This role will ensure adherence to company policies and procedures with quality standards internally and externally. This role will have ownership, oversight and impact on local regulatory and financial compliance and for out-tasking as applicable.

This role oversees teams and functions critical to clinical trial start-up and site engagement. The individual will manage a subset of CRA Managers and CRAs who are dedicated to validating clinical trial sites, as well as the Site Relationship Management (SRM) Organization, ensuring robust site relationships and operational excellence. Additionally, the role encompasses direct management of Senior Clinical Operation Managers (Sr. COMs), Clinical Operation Managers (COMs), and Clinical Trial Coordinators (CTCs). Strategic leadership is also provided for the Site Relationship Managers, guiding their approach to building and sustaining site partnerships. Furthermore, the role is responsible for driving innovative strategies in territory development, including oversight of the territory development lead, and for crafting approaches to “just in time” site management and site engagement, ensuring agility and responsiveness in clinical trial operations.

Primary responsibility for the role includes:

• Identify and implement innovative solutions to streamline start-up timelines, leveraging technology, reengineering processes, and best practices.

• Define site engagement strategy and site relationship management model.

• Proactively assess potential risks and bottlenecks in study start-up, developing mitigation plans and contingency strategies to ensure successful study launches.

• Build and mentor a high-performing team of study start-up professionals, fostering a culture of accountability, collaboration, and continuous improvement.

• Oversee the performance management and career development of staff and effectively manage performance issues

• Work closely with US CRDs, HSMM/CRA-Manager and TA-Heads to assess program strategy and alignment of project deliverables and objectives

• Partners with Headquarters-based colleagues help drive GCTO RRO strategy, with specific focus on standards of practice for site budgeting, site contracting, Informed Consents, and management of Central IRBs and applicable Health Authorities. Create, promote, and direct a strategy for rapid start up activities.

• Establish procedures and processes for all relevant activities (managing site contracts and budget negotiation and escalation, regulatory submissions and approvals; procedures and processes for managing logistics and purchasing of drugs and materials for study start up.)

• Responsible to ensure all projects are adequately resourced and tracked to ensure optimal efficiency and attainment of goals, milestones, and targets while ensuring high quality standards are maintained

• Establishing a strategy for partnering and monitoring all vendors/service providers that support operational implementation and management of Sr. COM, COM and CTC responsibilities. (Includes strategic oversight, providers, Central IRB vendors, etc.)

• Collaborates internally with CRDs, TAHs, CRA managers, Monitoring Excellence, Vendor management, Vendor Strategy and Management to develop and build the territory of principal investigators and sites.

Educational Requirement:

• Required: Bachelor of Science (or equivalent)

• Preferred: Master of Science or Medicine (or comparable)

Required Experience and Skills:

• 15 years of experience within the Pharmaceutical Industry of which at least 12 years of experience are in a clinical trial organization including experience in all clinical trial startup and ongoing management activities and processes.

• 7 years of experience in a functional management position

• Expert knowledge of clinical trial regulations (FDA, EMA, ICH-GCP) and site activation processes.

• Knowledge of clinical trial operations from a clinical research site perspective

• Proven ability to manage complex projects, drive results, and influence cross-functional teams.

• Exceptional communication, negotiation, and stakeholder management skills.

• Strong analytical and problem-solving abilities.

Preferred Experience and Skills:

• CRA experience.

• Management of CRAs and familiarity with outsourcing and flexible resource models.

• Experience with an innovation and study start up environment.

• Demonstrated success leading large, global clinical trial start-up initiatives in a pharmaceutical or biotechnology environment.

• Experience with digital platforms and technology-enabled study start-up solutions.

• Experience managing personnel and processes in a matrix managed organization.

• Working with multiple external partners with adequate controls, governance, and oversight.

Required Skills:

Budget Management, Clinical Trial Development, Clinical Trial Management, Clinical Trial Planning, Clinical Trial Protocols, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Executive Leadership, Innovation, People Leadership, Regulatory Governance, Resource Allocation, Risk Management, Study Start Up, Team Development

Preferred Skills:

Clinical Research

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

$255,800.00 - $402,700.00

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:

25%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

03/12/2026

*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.