Homebased Country Study Manager – DOCS
3.9.2022https://www.linkedin.com/jobs/view/3165849261
About the job
We are growing our EMEA Team and looking for solid managers to join our exciting new oncology programme. We have an open career opportunity for a Country Study Manager homebased in Finland.
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. global leads, global clinical project managers, etc.
- 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.)
Opportunities at ICON Global Strategic Solutions offer a competitive salary and benefits package and career development.
If you are open to discussing a new role, please apply for consideration and to arrange a call.