Clinical Research Study Start-up and Contract Specialist
Backround & Qualifications
- University degree, preferably from Healthcare related areas (Pharmacy, Chemistry, Biology, Medical etc. Faculties),
- Good level of English,
- Minimum 3 years’ experience in the pharmaceutical industry and minimum 2 year’s experience in clinical trial investigator start up including contracting, budgeting and negotiation
- Strong communication and negotiation skills,
- Ability to prioritize and handle multiple tasks,
- Basic coaching skills and good at team work,
- Effective planning and organizational skills with result-oriented approach,
- Stakeholder management experience,
- Analytical thinking, critical reasoning ability,
- Good command of MS Office applications,
- No restriction to travel,
- Driving License,
- No military obligation for male candidates.
• Serve as the primary point of contact for the Start-up and Contract Specialist during start-up on allocated projects.
• Serve as a subject matter expert for all issues relating to contracts and grants department processes and corporate/procurement/AstraZeneca policies and procedures for contracts and grants functions.
• Assume primary responsibility for tracking, maintenance and accuracy of metrics, contract documents, and supporting documentation.
• Reviews essential document packages for site activation and also be involved in essential document collection from sites.
• Prepares and submits Central EC Applications, RA Applications as required. Prepares ongoing submissions, amendments, and periodic notifications required by central EC and RA, and other local regulatory authorities as needed within the country
• Establish master agreements, lean process enhancements and other innovative solutions to expedite site initiation
• Review, authorize and/or manage payments where appropriate. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.