Clinical Operations Manager

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company, one that is ready to help create a healthier future for all of us.

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

• Expertise of core clinical systems, tools and metrics

• Excellent verbal and written influencing and training/mentoring skills, in local language and English

• Strong coordination and organizational skills

• Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.

• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager.

• Ability to make decisions independently with limited oversight from Sr.COM or manager.

• Requires strong understanding of local regulatory environment

• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

• Ability to lead a team of CTCs as applicable

BEHAVIOR COMPETENCY EXPECTATIONS:

• Problem solving is essential to this position. Requires the 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) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.

• Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills.

• High sense of accountability and urgency in order to properly prioritize deliverables

• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.

• Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.

• Positive mindset, growth mindset, capable of working independently and being self-driven

• Able to directly influence site staff

EXPERIENCE REQUIREMENT

• 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

• Bachelors Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R255642