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Clinical Operations Manager (COM)

Employer
Labcorp
Location
Brussels, Belgium
Salary
Competitive
Start date
1 Sep 2021
Closing date
27 Sep 2021

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Labcorp Drug Development client's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Essential Job Duties
  • Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
  • Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles.
  • 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.
  • Manages 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 Headquarter to align country timelines for assigned protocols.
  • Provides support and oversight to local vendors as applicable.
  • Ownership of 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.
  • Required to in/directly influence investigators, external partners and country operations to adhere to 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.
  • Oversees and coordinates 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.
Education/Qualifications:
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
  • Expertise of core clinical systems, tools and metrics
  • Excellent English skills
  • Strong coordination and organizational skills
  • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-ups
  • 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 SCOM or manager.
  • Requires strong understanding of local regulatory environment
  • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Experience:
  • 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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