Study Start Up Manager (Oncology)
- İstanbul
- Kontrat
- Tam zamanlı
- University degree, preferably from Healthcare related areas (Pharmacy, Chemistry, Biology, Medical etc. Faculties),
- Good level of English,
- Minimum 1 years' experience in clinical trial start up phase including prepare, review, track and manage site regulatory documentation
- 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.
- Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;
- Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
- Actively participates in Local Study Team (LST) meetings.
- Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
- Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
- Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Support QC checks performed by LSAD or delegate to ensure that 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 AZ SOPs
- 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.
Vacancies in Turkey