Clinical Operations Manager - Regulatory

Job Title: Clinical Operations Manager (COM/COM-F/COM-R) Position Purpose:

The Clinical Operations Manager (COM/COM-F/COM-R) is responsible for the following:

• Performance and compliance for assigned protocols in a country in compliance with International Committee on Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready under the oversight of the Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD).

This position has significant impact on the delivery of country specific trial commitments and objectives especially during study start-up. Organizational

Relationships

• Works in partnership internally with Global Clinical Trial Organization (GCTO) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarter (HQ) functional areas and externally with vendors and sites, Internal Review Board (IRB) / Internal Ethics Committee (IEC) and Regulatory Authorities in submission and approval related interactions.
• Reports to Parexel FSP assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.

Primary Responsibilities

• Oversees and coordinates local processes, clinical and ancillary supplies, import and export requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
• Coordinates and liaises with Clinical Research Managers (CRMs), Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs), Finance and Legal if appropriate to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements (CTRAs) and local milestones.
• Contributes to the development of local SOPs.
• Provides support and oversight to local vendors as applicable.
• Collaborates closely with Headquarter to align country timelines for assigned protocols.
• Contributes strongly to the COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement, and providing training as appropriate/required.
• Has ownership of local regulatory and financial compliance.
• Adheres to Parexel FSP and Client SOPs and processes.
• Delivers clinical and financial contracts within fair market value through continual interaction with local clinical teams.
• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.
• Contributes to COM team knowledge by acting as a buddy/mentor and sharing best practices as appropriate/required.
• Oversees CTCs as applicable.
• Manages country deliverables, timelines, and results for assigned protocols to meet country commitments including quality and compliance in assigned protocols in country.
• Contributes or leads initiatives and projects adding value to the business.

Finance

• Has ownership of country and site budgets including development, negotiation, and completion of Clinical Trial Research Agreements (CTRA).
• Oversees and tracks clinical research‐related payments and payment reconciliation at study close‐out.
• Influences investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines.
• Oversees Foreign Corrupt Practices Act (FCPA), Denied Party Screening/Office of Foreign Assets Control (DPS/OFAC) and maintenance of financial systems and financial forecasting in conjunction with SCOM, CRD and other roles.

Regulatory

• Developslocal language materials including local language Informed Consents and translations.
• Interacts with Institutional Review Boards (IRB)/Independent Ethics Committee (IEC) and Regulatory Authority for assigned protocols.
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.

Education And Certification

• Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.

Skills And Experience

• 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.
• 5‐7 years clinical research or combined experience in Clinical Research and Finance/Business.
• Requires a strong understanding of local regulatory environment.
• Problem solving is essential. Requires ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate to management as applicable.
• Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager.
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
• Expertise of core clinical systems, tools, and metrics.
• Ability to lead a team of CTCs as applicable.
• Ability to make decisions independently with limited oversight from SCOM or manager.

Examples Include

• Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
• Expertise of core clinical, regulatory, and financial systems, tools, and metrics.
• Quality and compliances issues
• Effective and efficient time management, organizational and interpersonal skills, and conflict management skills.
• Ability to focus on multiple deliverables and protocols simultaneously.
• High sense of accountability and urgency to prioritize deliverables.
• Positive mindset, growth mindset, capable of working independently and self – driven.
• Issues in budget/CTRA negotiation
• Issues related to functional area deliverables that could jeopardize protocol milestones
• Ability to directly influence site staff.
• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills.
• Regulatory and legal issues

Language Skills

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

Other Requirements

• Minimal travel required