Clinical Operations Manager-F- budgets and contracts - FSP

Parexel•Southport, NC

About The Position

The Clinical Operations Manager Finance (COM-F) is responsible for performance and compliance for assigned country protocols in accordance with ICH/GCP, country regulations, client policies and procedures, quality standards, and adverse-event reporting requirements. The role also manages budget and finance matters and oversees country clinical-trial submissions and approvals to support site readiness under the oversight of a Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD). The position has significant impact on delivery of country-specific trial commitments and objectives, particularly during study start-up. The role manages country deliverables, timelines, and results; coordinates with clinical operations, finance, legal, regulatory, and other functions; and works with sites, vendors, ethics committees, and regulatory authorities. It oversees applicable local processes, supplies, import/export requirements, filing, archiving, insurance, and country information in clinical and finance systems. Financial responsibilities include country and site budgets, contract negotiation and completion, payment oversight and reconciliation, compliance screening, and financial forecasting. The position may also execute country regulatory submissions and approvals and develop local-language materials. The COM-F contributes to team knowledge, process improvement, training, and mentoring, and complies with Parexel training, timekeeping, expense, CV, and applicable process requirements. Minimal travel is required; the individual must also be effective working remotely in a virtual environment.

Requirements

Strong coordination and organizational skills.
Skilled knowledge of budget and contract negotiations, the local regulatory environment, and submission and approval processes, including their impact on 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 the SCOM or manager.
Strong understanding of the local regulatory environment.
Ability to lead a team of Clinical Trial Coordinators as applicable.
Strong problem-solving skills, including proactively identifying issues and risks, analyzing root causes, proposing solutions, and escalating to management as appropriate.
Effective time management, organizational, interpersonal, and conflict-management skills.
High accountability and urgency in prioritizing deliverables.
Strong communication, leadership, negotiation, influencing, training, and mentoring skills.
Ability to manage multiple deliverables and protocols simultaneously.
Ability to work effectively in a remote virtual environment with a wide range of people.
Positive and growth-oriented mindset; able to work independently and be self-driven.
Ability to directly influence site staff.
Excellent verbal and written influencing and training/mentoring skills in the local language and English.

Responsibilities

Manage country deliverables, timelines, and results for assigned protocols, meeting country commitments and quality and compliance requirements.
Oversee Clinical Trial Coordinators as applicable.
Coordinate with Clinical Research Managers, Clinical Research Associates, Clinical Trial Coordinators, Finance, and Legal to obtain country deliverables for submissions, budgets, Clinical Trial Research Agreements (CTRAs), and local milestones.
Collaborate with headquarters to align country timelines for assigned protocols.
Provide support and oversight to local vendors as applicable.
Oversee and coordinate local processes, clinical and ancillary supplies, import/export requirements, supply destruction, local electronic and hard-copy filing, archiving and retention, and insurance process management.
Enter and update country information in clinical and finance systems.
Deliver clinical and financial contracts within fair market value through ongoing interaction with local clinical teams.
Partner with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functional areas, vendors, sites, IRBs/IECs, and regulatory authorities on submissions and approvals.
Own country and site budgets, including development, negotiation, and completion of CTRAs, as applicable.
Oversee and track clinical research-related payments and payment reconciliation at study close-out.
Oversee FCPA and DPS/OFAC requirements and maintain financial systems and financial forecasts with the SCOM, CRD, and other roles, as applicable.
Influence investigators, external partners, and country operations to meet budget targets and agreed payment timelines.
Execute and oversee country clinical-trial submissions and approvals for assigned protocols, as applicable.
Develop local-language materials, including informed consents and translations, as applicable.
Interact with IRBs/IECs and regulatory authorities for assigned protocols, as applicable.
Contribute to or lead business initiatives and projects.
Share best practices, recommend continuous improvements, provide training, and act as a process subject matter expert as appropriate.
Act as a buddy or mentor and share best practices as appropriate.
Complete required training, timesheets, expense reports, and CV updates, and maintain working knowledge of and comply with Parexel processes, ICH-GCP, and other applicable requirements.
Develop country risk-management and mitigation plans, resolve issues locally, identify risks and root causes, propose solutions, and escalate issues when appropriate.