İş İlanları Ümraniye, i̇stanbul, turkey

The position

As CDC Start-up Trial Manager, you will be responsible from all start-up related deliverables from Feasibility to activations of all planned sites including country First Patient First Visit (FPFV), and responsible for achieving deliverables within agreed timelines and quality measures. You will be leading the CDC project team, including start-up specialists, contract specialists, import team, CRAs and CTAs to ensure timely start of assigned clinical trials. Besides you will be also responsible for budgets, timeline, quality in the start-up phase of the trial, proactively identifying any risks in start-up and site activation plans and developing and implementing mitigation strategies as required and representing CDC countries in study meetings, as relevant.Your other responsibilities will be to : Project management of assigned clinical trials in start-up within the CDC country and adjacent affiliates; responsible from strategy, planning, risk analyses and management of feasibility, site selection, submission, contracts and budget, import and clinical supply process, greenlight and activationLiaise with the regulatory colleagues and country operations colleagues to agree on submission strategy to Health Authorities and Ethic Committees and other authorities, handle global / CDC issues on submission process and follow up on main activities on the readiness of CTA package submission and oversight for CDC and Adjacent AffiliatesEnsure COSMOS set-up & updates are done at country level and site level (for adjacent affiliates); oversight and compliance check of e-TMF for assigned clinical trials in close collaboration with responsible roles, track site trainings through CRA responsible, ensure sites are ready to be activated, provide greenlight for activationResponsible for timely and effective communication between relevant roles, such as SSU- CTA, Monitor’s in adjacent affiliates and CDC and global trial management, internal and external stakeholders. Keep CDC Trial Manager (TM) updated on the progress from Site selections to site greenlight.Responsible for representing CDC countries in study meetings as relevant : Monitor meetings, Investigator meetings and planning and execution of local / regional Investigator meetings as relevant The QualificationsYou have bachelor level Life Science, pharmacy, nursing or equivalent education with experience on start-up project management of clinical trials in pharmaceutical industry or Clinical Research Organization (CRO) (desirable), including multi-centre studies. Demonstrating proficiency in clinical trial start-up related roles and trial management with a minimum experience of 3 years (Pharmaceutical industry or CRO) is required. You should also have; Ability to communicate with impact, and build and maintain strong relationships with internal and external stakeholders across organisational levelsIndependence, innovation, and initiative should always be demonstrated when analysing, prioritizing, planning and performing tasks either assigned by management or initiated by oneselfUnderstanding of all aspects of operational clinical trial methodology and drug development process and understanding of clinical trial regulations / requirements of other countries in addition to TürkiyeGCP training attended and certifiedKnowledge of the clinical trials environment – ICH GCP, regulatory issues, SOPs and good working knowledge of electronic clinical trials systems – COSMOS, EDC, IWRS, electronic TMFStrong problem-solving skills with solution oriented and with a quality mind setExcellent oral and written English skillsExcellent presentation, analytical, communication, negotiation, computer literacy and IT skillsAbility and willingness to adjust quickly to new situations in a continuously developing environmentDemonstrating and fostering a team culture of best practice sharing, providing innovative solutions and openness to share learnings About the Department Clinical Development Centre Türkiye is responsible for all clinical operations activities within Türkiye and project management of clinical studies conducted in Saudi Arabia, Lebanon, Algeria, and Morocco. The team consists of more than 80 employees as TAs team members, Clinical Operations Excellence team members and start up team membersWorking at Novo NordiskNovo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 63, employees. Together, we go further. Together, we’re life changing.