Ref #: 38270
Employment type: Permanent - Full-Time
Location: Latvia
Posted: 17-Jun-2022
Description
The Country Study Manager is an integral 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 Strategic Solutions offer scope for learning, training and career development.
If you are open to discussing a new role, please apply for consideration and to arrange a call.
Note
ICON acquired PRA and we are now a much larger organization offering plenty of career scope and potential - this became official on 1st of July 2021 - https://www.iconplc.com/about/company-history/
DOCS is a division of ICON - DOCS and PRA have been rebranded ICON Strategic Solutions (ISS).
ISS is the World Leader in FSP.
If you are seeking an international company who is committed to development and training with the opportunity for career progression, please contact me.
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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 Strategic Solutions offer scope for learning, training and career development.
If you are open to discussing a new role, please apply for consideration and to arrange a call.
Note
ICON acquired PRA and we are now a much larger organization offering plenty of career scope and potential - this became official on 1st of July 2021 - https://www.iconplc.com/about/company-history/
DOCS is a division of ICON - DOCS and PRA have been rebranded ICON Strategic Solutions (ISS).
ISS is the World Leader in FSP.
If you are seeking an international company who is committed to development and training with the opportunity for career progression, please contact me.
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.