Parexel FSP is looking for a Clinical Operations Manager- FINANCE. This role requires 1-day minimum onsite requirement in Kirkland Quebec.
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 :
May include but not limited to the following
Study Management
Manages country deliverables, timelines, and results for assigned protocolsto meet country commitments including quality and compliance in assigned protocols in country
Oversees Clinical Trial Coordinators as applicableCoordinates 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 milestonesCollaborates closely with Headquarter to align country timelines for assignedprotocols
Provides support and oversight to local vendors as applicableOversees 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 throughcontinual interaction with local clinical teams
Works in partnership internally with Global Clinical Trial OrganizationGCTO) 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 paymentreconciliation 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 rolesInfluences 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 protocolsTeam 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 abuddy / mentor and sharing best practices as appropriate / required
Compliance with Parexel standards
Complies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintain a working knowledge of and comply with Parexel processes, ICH- GCPs and other applicable requirementsSkills :
Strong coordination and organizational skills.Skilled knowledge of budget and contract negotiations, local regulatory environmentand 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 managerAbility to make decisions independently with limited oversight from SCOM or manager.Requires a strong understanding of local regulatory environmentAbility to proactively develop risk management and mitigation plans in the country and resolve issues locallyAbility to lead a team of CTCs as applicableProblem 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 :
o 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 interpersonalskills, and conflict management skills
High sense of accountability and urgency to prioritize deliverablesStrong communication, leadership, and negotiation skills as well as excellent influencing and training / mentoring skillsAbility to focus on multiple deliverables and protocols simultaneouslyRequires that the individual has ability to work effectively also in a remote virtual environment with a wide range of peoplePositive mindset, growth mindset, capable of working independently and self – driven.Ability to directly influence site staffExcellent verbal and written influencing and training / mentoring skills, in local language andEnglish
Minimal travel requiredKnowledge and Experience :
5-7 years clinical research or combined experience in Clinical Research and Finance / BusinessExpertise of core clinical, regulatory, and financial systems, tools, and metricsEducation :
Bachelor's Degree in Business Finance / Administration / Life Science or equivalentHealth Care related experience