Clinical Operations Manager-FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel has an exciting opportunity for a Clinical Operations Manager (Finance)! This is a hybrid role in Canada.

Job Purpose:The Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/ Clinical Operations Manager Regulatory (COM-R) is responsible for the following:• Performance and compliance for assigned protocols in a country in compliance with International Council for 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 andapprovals 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.

Key Accountabilities:Study Management• Manages country deliverables, timelines, and results for assigned protocolsto meet country commitments including quality and compliance in assignedprotocols in country• Oversees Clinical Trial Coordinators as applicable• Coordinates and liaises with Clinical Research Managers (CRMs), ClinicalResearch Associates (CRAs) and Clinical Trial Coordinators (CTCs),Finance and Legal if appropriate to ensure country deliverables are obtainedfor submissions, budgets, Clinical Trial Research Agreements (CTRAs) andlocal milestones• Collaborates closely with Headquarter to align country timelines for assignedprotocols• Provides support and oversight to local vendors as applicable

Oversees and coordinates local processes, clinical and ancillary supplies,import and export requirements, supplies destruction, local electronic/hardcopy filing, archiving and retention requirements, and insurance processmanagement. Enters and updates country information in clinical and financesystems• Delivers clinical and financial contracts within fair market value throughcontinual interaction with local clinical teams• Works in partnership internally with Global Clinical Trial Organization(GCTO) country operations, finance, regulatory affairs, pharmacovigilance,legal and regional operations, Headquarter (HQ) functional areas andexternally with vendors and sites, Internal Review Board (IRB) / IndependentEthics Committee (IEC) and Regulatory Authorities in submission andapproval related interactions

Finance Management (as applicable)• 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 paymentreconciliation at study close-out• Oversees Foreign Corrupt Practices Act (FCPA), Denied PartyScreening/Office of Foreign Assets Control (DPS/OFAC) and maintenanceof financial systems and financial forecasting in conjunction with SeniorClinical Operations Manager, Clinical Research Director and other roles• Influences investigators, external partners, and country operations to adhereto budget targets and agreed payment timelines

Regulatory Management (as applicable)• Executes and oversees clinical trial country submissions and approvals forassigned protocols• Develops local language materials including local language InformedConsents and translations• Interacts with IRB/ IEC and Regulatory Authority for assigned protocols

Team development and support• Contributes or leads initiatives and projects adding value to the business.• Contributes strongly to the Clinical Operations Manager team and otherCountry Operations roles knowledge by acting as process Subject MatterExpert (SME), sharing best practices, making recommendations forcontinuous improvement and providing training as appropriate/required.• Contributes to Clinical Operations Manager team knowledge by acting as abuddy/mentor and sharing best practices as appropriate/required

Compliance with Parexel standards• Complies with required training curriculum• Completes timesheets accurately as required• Submits expense reports as required• Updates CV as required• Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements

Skills:• 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 SCOM or manager• Ability to make decisions independently with limited oversight from SCOM or manager.• Requires a 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• Problem solving is essential. Requires ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate to management as applicable.

Examples include:Issues in budget/CTRA negotiationo Quality and compliances issueso Regulatory and legal issueso Issues related to functional area deliverables that could jeopardize protocol milestones• Effective and efficient time management, organizational and interpersonalskills, and conflict management skills• High sense of accountability and urgency to prioritize deliverables• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills• Ability to focus on multiple deliverables and protocols simultaneously• 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 self – driven.
• Ability to directly influence site staff
• Excellent verbal and written influencing and training/mentoring skills, in local language and English
• Minimal travel required.

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