Description
Clinical Operations Manager - Sponsor Dedicated
Regulatory And Monitoring Experience Is Preferred
Based in Istanbul
Main Responsibilities Include
Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversight and tracking of clinical research‐related payments. Payment reconciliation at study close‐out. Oversight of FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting 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. Interactions with IRB/IEC and Regulatory Authority 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 country. Contributes to the development of local SOPs. Oversees CTCs as applicable.
Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) 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. 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 and finance systems.
Has ownership, oversight and impact on local regulatory and financial compliance. The position has a significant impact on how a country can deliver country‐specific trial commitments and objectives especially during study start‐up.
Working closely with the CRD and local GCTO country operation to assess, prioritize and drive execution of specific clinical trials in order to support and manage the pipeline and local business needs to agreed timelines and budgets. Required to in/directly influence investigators, external partners and country operations to adhere to budget targets and agreed payment timelines.
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/IECs and Regulatory Authorities in submission and approval related‐interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Requires skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start‐up.
Able to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the CRD.
Requires ability to make decisions independently with limited oversight from CRD. Able to manage important activities relevant to clinical research activities in the country according to predetermined global policies and commitments. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
Problem solving is essential to this position. Requires the ability to pro‐actively identify issues and risks, analyze 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.
Position requires extensive experience in clinical research operations and experience with project management and coordination.
Qualifications
What we’re looking for
The ideal candidate will need the following experience / skills to be considered:
- 4‐5 years or more clinical research experience in SSU and Monitoring stages
- Requires expertise of core clinical systems, tools and metrics
- Excellent English skills required
- Strong coordination and organizational skills required
