Director of Biogas Projects managing complete EPC project execution. Overseeing engineering, procurement, construction, and HSE compliance at Solarig for renewable energy solutions.
About the role
- Lead and coordinate Local Study Teams for clinical studies across multiple countries. Ensure compliance with guidelines and timely delivery of study commitments for IQVIA.
Responsibilities
- To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
- Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
- Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
- Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports.
- Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with Sponsor SOPs.
- Proactively identifies risks and facilitates resolution of complex study problems and issues.
- Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
- Plans and leads National Investigator meet to ensure compliance with Sponsor´s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Requirements
- Bachelor degree in related discipline, preferably in life science, or equivalent qualification
- Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies)
- Good medical knowledge and ability to learn relevant Sponsor Therapeutic Areas
- Excellent understanding of the Clinical Study Process including monitoring
- Very good understanding of the Study Drug Handling Process and the Data Management Process
- Excellent ability to prioritize and handle multiple tasks, attention to details and negotiation skills.
- Excellent knowledge of spoken and written English and local languages.
- Ability to travel nationally and internationally as required
Benefits
- Excellent project management skills
- Excellent team building and interpersonal skills
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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