Associate Clinical Operations Manager 1 (aCOM 1)

Job Description

Brief Description of Position

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company's 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 Supporting budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals.

Responsibilities Include But Are Not Limited To

• Support to country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Oversees and tracks clinical research-related payments. Payment reconciliation at study close- out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Support of Financial forecasting in conjunction with Sr.COM /other roles.
• Contribute to Execution and oversight of clinical trial country submissions and approvals for assigned protocols.
• Develops working knowledge of local language materials including local language Informed Consents and translations. May interact with IRB/IEC and Regulatory Authority for assigned protocols.
• Supports country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Contributes to the development of local SOPs.
• Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
• Provide support to local vendors as applicable.
• Support local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements. Enters and updates country information in clinical and finance systems.
• Support of local regulatory and financial compliance.
• Acquire knowledge how to in/directly influence investigators, external partners and country operations and adheres to budget targets and agreed payment timelines.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related- interactions with support of an experienced COM. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
• Contribute to initiatives and projects adding value to the business, as appropriate/required.
• Contributes to COM team and other Country Operations roles knowledge by acting as/supporting process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement as appropriate/required.
• Contributes to COM team knowledge by sharing best practices as appropriate/required.

Qualifications & Experience

• 1-2 years of experience in Clinical Research or experience in Finance/Business
• Required Associate degree or equivalent Health Care related experience
• Preferred Bachelors degree

Skills Required

• Good IT skills (MS office, Clinical IT applications) and ability to adapt to new IT applications on various devices.
• Excellent verbal and written skills, in local language and English.
• Strong coordination and organizational skills.
• Basic knowledge of budget and contract negotiation process, local regulatory environment and submission and approval processes, and understanding of how these impact study start-ups.
• Ability to propose solutions to local study teams.
• ICH/GCP knowledge appropriate to role. Hands on knowledge of Good Documentation Practices.
• Able to work with other experienced clinical research professionals to learn and develop skills to manage protocols independently. Works with high quality and compliance mindset.
• 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 and negotiation skills 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 & growth mindset, capable of working independently and being self-driven.

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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

Regular

Relocation

VISA Sponsorship

Travel Requirements

Flexible Work Arrangements

Shift

Valid Driving License

Hazardous Material(s)

Requisition ID R266925