CDC Start-up Trial Manager

İstanbul
Kontrat
Tam zamanlı

1 ay önce

Are you an expert in project management of clinical trials in start-up? Would you like to use your experience to continuously optimise the way trials are conducted? Do you want to be part of our Clinical Development Centre (CDC) which includes Türkiye, Saudi Arabia, Lebanon, Algeria, and Morocco? Join Novo Nordisk as CDC Start-up Trial Manager and get a life-changing career! This role is based in Istanbul or Ankara, Türkiye, and directly reports to CDC Study Start-up Head.The positionAs 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 activation
Liaise 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 Affiliates
Ensure 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 activation
Responsible 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 levels
Independence, innovation, and initiative should always be demonstrated when analysing, prioritizing, planning and performing tasks either assigned by management or initiated by oneself
Understanding 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 Türkiye
GCP training attended and certified
Knowledge of the clinical trials environment - ICH GCP, regulatory issues, SOPs and good working knowledge of electronic clinical trials systems - COSMOS, EDC, IWRS, electronic TMF
Strong problem-solving skills with solution oriented and with a quality mind set
Excellent oral and written English skills
Excellent presentation, analytical, communication, negotiation, computer literacy and IT skills
Ability and willingness to adjust quickly to new situations in a continuously developing environment
Demonstrating and fostering a team culture of best practice sharing, providing innovative solutions and openness to share learnings

About the DepartmentClinical 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 63,400 employees. Together, we go further. Together, we're life changing.ContactTo submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Internal candidates are kindly requested to inform their line Manager before applying.Deadline24 July 2025We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.To help us track our recruitment effort, please indicate in your cover/motivation letter where (vacanciesinturkey.com) you saw this job posting.

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