Senior Clinical Operations Manager (COM)-Regulatory Manager

Job Description

Position Description:

Senior Clinical Operations Manager (COM)-Regulatory Manager

This role is accountable for execution and oversight of local operational clinical trial activities in compliance with International Council for Harmonization Good Clinical Practice (ICH-GCP) and country regulations, our Company's policies and procedures and with quality standards internally and externally.

The person has ownership, oversight and impact on local regulatory and financial compliance and for out-tasking as applicable. Under the oversight of the Clinical Research Director (CRD) orClinical Operations Manager (COM), the person is responsible to manage/oversee a team of Clinical Operations Manager (COM) and/or Clinical Trial Coordinator (CTCs).

Responsibilities include, but are not limited to:

• Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up:

MANAGEMENT & QUALITY OVERSIGHT:

• Responsible for managing country deliverables, timelines and results in assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to development of local/Int'l SOPs.
• Oversees CTCs and contract workers (e.g. CTCs) and local vendors and may manage COMs, both as applicable.

COLLABORATION:

• Works with minimal oversight from CRD or COM manager in close collaboration internally with GCTO Country Operations (CRM, CTC, CRA, COM and CQM), Medical Affairs, PV, Regulatory Affairs, Business Compliance, MRL/Local finance departments, legal, HQ functional areas and externally with vendors and sites to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
• Collaborates closely with Regional Operations and/or Headquarters to align country timelines for assigned protocols.
• Provides support and oversight to local vendors as applicable.

LOCAL PROCESS OVERSIGHT:

• Oversight and coordination of local processes; clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, insurance process management.
• Enters and updates country information in clinical, regulatory, safety and finance systems.
• Contribute or lead initiatives and projects adding value to the business, as appropriate/required.

Extent of Travel: Minimal travel required.

CORE Competency Expectations:

• Demonstrates proactive leadership and must be able to in/directly influence investigators, vendors, external partners and country managers to deliver these commitments within specified timelines and budgets, with minimal oversight from the line manager.
• Skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment and submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and takes ownership of decisions.
• Extensive experience with clinical project management and coordination.
• Expertise of core clinical, regulatory and financial systems, tools and metrics.
• Extensive knowledge of local regulatory environment and submission and approval processes.
• Strong coordination and organizational skills.
• Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.
• Demonstrates leadership behaviors.

Behavioral Competency Expectations:

• Problem solving and Process Improvement is essential to this position.
• Ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Quality and compliance issues, 2) Regulatory and legal issues, and 3) issues related to functional area deliverables that could jeopardize protocol milestones.
• Strong communication and leadership skills.
• Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal.
• People management skills (also across countries) will be valued.
• Ability to focus on multiple deliverables and protocols simultaneously is essential.
• Ability to work effectively also in a remote virtual environment with a wide range of people and understanding of cultural differences.
• Fluency in both English and local language.

Position Qualifications:

Education Minimum Requirement:

• Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science.

Required Experience and Skills:

• 8 years of experience in clinical research

Preferred Experience and Skills:

• Master's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.

Additional (Budget/headcount):

• Could manage a team of 6-14 company employees as direct reports (COMs and/or CTCs).
• Oversees contractor CTCs and or COMs, as applicable.

#EligibleforERP

MRLGCTO

NOTICEFORINTERNALAPPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected salary range:
$130,960.00 - $206,200.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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

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:
Remote Work

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
No

Requisition ID:R252426