(Associate) Clinical Operations Manager

Job Description

Join our company, a premier research-intensive biopharmaceutical company, at the forefront of delivering innovative health solutions. We are dedicated to advancing the prevention and treatment of diseases in people and animals. As an (Associate) Clinical Operations Manager, you will play a crucial role in managing clinical trials and ensuring compliance with regulatory standards. This is an exciting opportunity to contribute to our mission of using leading-edge science to save and improve lives around the world.

Your Key Contributions

• You'll take ownership of country and site budgets, developing, negotiating, and completing Clinical Trial Research Agreements (CTRA).
• Oversee and track all clinical research-related payments.
• You'll execute and oversee clinical trial country submissions and approvals for assigned protocols.
• Manage country deliverables, timelines, and results to meet our commitments.
• Ensure top-notch quality and compliance in all assigned protocols within the country.
• Contribute to the development of local Standard Operating Procedures (SOPs) and oversee Clinical Trial Coordinators (CTCs) as needed.
• You'll coordinate and liaise with Clinical Research Managers (CRM), CTCs, Clinical Research Associates (CRA), and other departments to ensure country deliverables are achieved.
• Collaborate closely with Headquarters to align country timelines for protocols.
• Provide support and oversight to local vendors where applicable.
• You'll manage local processes including supply management, importing/exporting, supplies destruction, filing, archiving, retention requirements, and insurance process management.
• Enter and update country information in clinical and finance systems.
• Work internally with various departments such as GCTO country operations, finance, regulatory affairs, and externally with vendors, sites, and regulatory authorities for submission and approval-related interactions.
• Deliver clinical and financial contracts within fair market value through continuous interaction with local clinical teams.

What You Bring to the Table

Required

• You have a Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.
• Minimum of 2-3 years of hands-on experience in clinical research or combined experience in Clinical Research and Finance/Business.
• Experience in regulatory or finance functions.
• You possess strong problem-solving skills with the ability to proactively identify issues and risks, analyze root causes, and propose effective solutions.
• Effective time management, organizational and interpersonal skills, conflict management, and problem-solving skills.
• A high sense of accountability and urgency to properly prioritize deliverables.
• Your communication, leadership, and negotiation skills are exceptional.
• Excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
• Ability to juggle multiple deliverables and protocols simultaneously with ease.

Preferred

• Additional experience in both regulatory and finance functions is considered a strong advantage.

Please note that there are three open vacancies for this role.

The final level of the position (associate COM I, associate COM II, or COM) will be determined based on the candidate’s actual experience and demonstrated capabilities in clinical trial activities.

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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.

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