Senior Clinical Operations Manager
2 weeks ago
This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our Company's policies and procedures and with quality standards internally and externally.
The person has ownership, oversight and impact on study operational activities and for out-tasking as applicable. Under the oversight of the CRD, the person is responsible to manage/oversee a team of Clinical Operations Managers (COMs) and/or Clinical Trial Co-ordinators (CTCs.)
**Responsibilities include, but are not limited to**:
Has significant impact on how a country or countries can deliver country-specific trial commitments and objectives especially during study start-up:
**LOCAL PROCESS OVERSIGHT**:
- Oversight and coordination of local processes; clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, insurance process management.
- Enters and updates country information in clinical, regulatory, safety and finance systems.
- Contribute or lead initiatives and projects adding value to the business, as appropriate/required.
**MANAGEMENT & QUALITY OVERSIGHT**:
- Responsible for managing country deliverables, timelines and results in assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to development of local/global SOPs.
- Oversees and trains CTCs and contract workers (e.g. CTCs) and local vendors and may manage COMs, both as applicable.
**FINANCIAL**:
- Working with Financial COM, takes ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Interacts successfully with local clinical team/s in order to deliver clinical and financial contracts within fair market value. Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, Denied Parties Screening and maintenance of financial systems. Financial forecasting and tracking of operational budget in conjunction with CRD is an option that can vary per country.
**COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS**:
- Responsible for oversight of clinical trial country submissions and approvals for assigned protocols, development of local language materials including local language Informed Consents and translations.
**COLLABORATION**:
- Works with mínimal oversight from CRD or COM manager in close collaboration internally with GCTO Country Operations (CRM, CTC, CRA, COM and CQM), Medical Affairs, PV, Regulatory Affairs, Business Compliance, MRL/Local finance departments, legal, HQ functional areas and externally with vendors and sites to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborates closely with Regional Operations and/or Headquarters to align country timelines for assigned protocols.
- Provides support and oversight to local vendors as applicable.
**Qualifications, Skills & Experience**
- ** Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.**
- ** Minimum 8 years of experience in clinical research.**
- Preferred: Master's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.
- Demonstrates proactive leadership and must be able to in/directly influence investigators, vendors, external partners and country managers to deliver these commitments within specified timelines and budgets, with mínimal oversight from the line manager.
- Skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment and submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and takes ownership of decisions.
- Extensive experience with clinical project management and coordination.
- Expertise of core clinical, regulatory and financial systems, tools and metrics.
- Extensive knowledge of local regulatory environment and submission and approval processes.
- Strong coordination and organizational skills.
- Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.
- Demonstrates leadership behaviours.
- Problem solving and Process Improvement is essential to this position.
- Ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems i
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