Ref #: 36061

Employment type: Permanent - Full-Time

Location: Sweden

Posted: 12-May-2022


In this role, you are a Member of the Global Clinical Studies Team and the primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and applicable local regulations. You will also maintain the quality and scientific integrity of clinical trials at a country level. In addition, you will collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables within the country.

Key responsibilities include;

• Planning, management and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)
• Accountable for study deliverables in that country.
• Leads country-level operational planning and supports site selection within assigned country(ies)
• Ensure relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
• Ensure key stakeholders are kept informed of study progress e.g. GCTM, DOM
• Ensure effective study risk management for assigned country(ies)
• Contribute to development of study-specific materials – e.g. monitoring plan, study specific training documents.
• Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training
• Oversight and monitoring of applicable vendor activities eg. laboratories and equipment provisioning
• Execute regulatory agency inspection readiness activities (e.g. TMF review, story board generation)
• Participate in cross-functional task forces/process improvement groups
• Identifying risk, implementing risk mitigation strategies and resolving issues at a country/site level
• Leading and continually reviewing country level risk mitigation activities to ensure study delivery to plan
You will need;
• University degree in Life/Health Sciences
• Minimum 3 years’ clinical trial management experience
• Minimum 3 years’ experience of leading local/regional or global teams
• 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)

We will offer a competitive salary and benefits package and career development.

If you are open to considering a new role, please apply for consideration and to arrange a call.