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 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.

Key Accountabilities

Study Management

• Manages country deliverables, timelines, and results for assigned protocols

• to meet country commitments including quality and compliance in assigned
• protocols in country

• Oversees Clinical Trial Coordinators as applicable
• 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

• Collaborates closely with Headquarter to align country timelines for assigned

protocols

• 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/hard
• copy filing, archiving and retention requirements, and insurance process
• management. Enters and updates country information in clinical and finance
• systems

• Delivers clinical and financial contracts within fair market value through

continual 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 and
• externally with vendors and sites, Internal Review Board (IRB) / Independent
• Ethics Committee (IEC) and Regulatory Authorities in submission and
• approval 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 payment

reconciliation at study close-out

• 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 Senior
• Clinical Operations Manager, Clinical Research Director and other roles

• Influences investigators, external partners, and country operations to adhere

• to budget targets and agreed payment timelines
• Regulatory Management (as applicable)

• Executes and oversees clinical trial country submissions and approvals for

assigned protocols

• Develops local language materials including local language Informed

Consents 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 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.

• Contributes to Clinical Operations Manager team knowledge by acting as a

• buddy/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 negotiation
• o Quality and compliances issues
• o Regulatory and legal issues
• o Issues related to functional area deliverables that could jeopardize protocol milestones

• Effective and efficient time management, organizational and interpersonal

skills, 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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