For a successful and innovative pharmaceutical company we are seeking for a Clinical Operations Manager with a focus on Study Start up and regulatory. Also very interesting for CRA’s who are looking for the next step!
The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. The incumbent must be able to indirectly influence investigators, vendors, external partners and country managers to deliver these commitments. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country based regulations, laws and procedures with minimal support from the CRD. The position requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment,submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.
Primary activities / responsibilities for the function as a Study Start up Specialist/Associate:
The COM/ Study Start up Specialist/Associate is accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Through continual interaction with local clinical team/s successfully delivers 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;
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols;
- Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to the development of local SOPs. May oversee contract workers (CTCs) and local vendors as applicable.
- Works in close collaboration internally with GCTO country operations (CRM, CTC,CRA), CQM, Finance, Medical Affairs, Regulatory Affairs, PV, Business Compliance, Legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable;
- Oversight and coordination of local processes. Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical, regulatory, safety and finance systems;
- Problem solving and Process Improvement is essential to this position. Requires the 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 include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
(full job description available)
The ideale profile:
- Bachelor’s Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience;
- 4-8 years clinical research experience;
- Expertise of core clinical, regulatory and financial systems, tools and metrics;
- Extensive knowledge of local regulatory environment and submission and approval processes;
- Effective communication and leadership skills;
- Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal;
- The ability to focus on multiple deliverables and protocols simultaneously is essential;
- Strong coordination and organizational skills;
- Fluency in English, Dutch language should be very good;
Behavioural Competency Expectations:
- Ethics & Integrity
- Focus on Customers
- Drive Results
A competitive package!
More info about this opportunity? Call or mail Albert Hollemans 06-22639519 or email@example.com