Clinical Operations Manager-F- budgets and contracts - FSP

Parexel

Any City, NCRemotePosted 5 days ago

Full TimeSenior LevelClinical DevelopmentCRO

Summary

The Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/Clinical Operations Manager Regulatory (COM-R) is responsible for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. Also responsible for budget/finance aspects, execution and oversight of clinical trial country submissions and approvals, and ensuring Site Ready under the oversight of the Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD).

Job description

Job Purpose

Key Accountabilities

Study Management

Manages country deliverables, timelines, and results for assigned protocols to meet country commitments including quality and compliance
Oversees Clinical Trial Coordinators as applicable
Coordinates and liaises with CRMs, CRAs, and CTCs, Finance and Legal to ensure country deliverables are obtained for submissions, budgets, 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, filing, archiving and retention requirements, and insurance process management
Delivers clinical and financial contracts within fair market value through continual interaction with local clinical teams
Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IEC and Regulatory Authorities

Finance Management

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 FCPA, DPS/OFAC and maintenance of financial systems and financial forecasting
Influences investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines

Regulatory Management

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
Acts as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training
Acts as a buddy/mentor and shares best practices

Compliance with Parexel Standards

Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Requirements

Strong coordination and organizational skills
Skilled knowledge of budget and contract negotiations
Knowledge of local regulatory environment and submission and approval processes
Understanding of how budget and regulatory processes impact study start-up
Ability to indirectly influence investigators, vendors, external partners, and country managers
Ability to make decisions independently with limited oversight
Strong understanding of local regulatory environment
Ability to proactively develop risk management and mitigation plans
Ability to lead a team of CTCs as applicable
Problem solving skills including root cause analysis and solution proposal
Effective time management, organizational and interpersonal skills
Conflict management skills
High sense of accountability and urgency
Strong communication, leadership, and negotiation skills
Excellent influencing and training/mentoring skills
Ability to focus on multiple deliverables and protocols simultaneously
Ability to work effectively in a remote virtual environment
Positive and 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

Company overview

Parexel is one of the world's largest and most prominent contract research organizations (CROs), providing comprehensive clinical research services to pharmaceutical and biotechnology companies globally. Founded in 1982 and headquartered in Raleigh, North Carolina, Parexel operates with a global workforce of over 24,000 professionals across 84+ facilities in 49 countries. The company specializes in managing the full spectrum of clinical trials from Phase I to IV across diverse therapeutic areas including neuroscience, oncology, infectious diseases, hematology, and general medicine. Parexel offers end-to-end solutions encompassing clinical trial management, regulatory strategy, data management, biostatistics, pharmacovigilance, medical communications, and market access consulting. With a strong track record spanning over 40 years, Parexel has established itself as a trusted partner for both established pharmaceutical leaders and emerging biotech innovators, helping accelerate drug development and bring life-saving treatments to patients faster through its patient-centric approach and operational excellence.