Staffing services voor de Life Sciences industrie
Filled

Study Start-up & Regulatory Manager in Amsterdam fulltime

Clinical Operations Amsterdam 40 hour W&S #1119

The organization

Ready for the next step? In this position you will be accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance.

The Position

Primary activities / responsibilities for the function as a clinical operations manager (study start up & regulatory manager):

The COM is accountable for execution and oversight of local operational clinical trial activities in the Netherlands for assigned protocols in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Besides these tasks you will be responsible for the financials, country submissions, management of quality and compliance, local process oversight and collaborations. The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

Main responsibilities are (summary)

  • Financial – 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.
  • Country Submission & Local Language Materials – 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.
  • Management & Quality Oversight – 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 SOP. May oversee contract workers and local vendors.
  • Collaborations – Country Operations, Medical Affairs, Regional Operations, Quality, PV, HQ functional area’s with vendors and sites, IRB/IEC’s and others
  • Local Process Oversight – responsible for clinical supplies management, problem solving & process improvement

(full job description available)

Profile

Requirements for the function as a clinical operations manager:

  • Bachelor’s Degree (or comparable) in Business Finance / Administration / Life Science or equivalent Health Care related experience;
  • 3-7 years clinical research experience;
  • Experience in clinical project management and coordination;
  • Expertise of core clinical, regulatory and financial systems, tools and metrics;
  • Knowledge of local regulatory environment and submission and approval processes;
  • Effective communication and leadership skills;
  • The ability to focus on multiple deliverables and protocols simultaneously is essential;
  • Ability to work effectively also in a remote virtual environment with a wide range of people;
  • Strong coordination and organizational skills;
  • Fluency in both English and Dutch.

More information

More info about this fantastic opportunity? Call or mail Albert Hollemans 06-22639519 or albert@heraklespharma.nl

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More information about this vacancy

Albert Hollemans

Associate Director Business Development