Senior Clinical Project Manager

14 hours ago

Stockholm, Stockholm, Sweden BioArctic Full time 100,000 - 200,000 per year

The Senior Clinical Project Manager has the overall responsibility for the planning and oversight of the conduct of assigned clinical trials under the sponsorship or agreement with BioArctic.

Key Role Responsibilities And Activities

  • Managing and leading all aspects of assigned clinical trials from planning stage to close-out and clinical study report. Responsible for setting up and maintaining agreed budgets, including checking invoices for correctness, for assigned clinical trials.
  • Selection, management, and sponsor oversight of Contract Research Organizations (CROs) and other vendors. Oversight and regular reporting of trial progress to ensure successful completion within agreed timelines and budget and to ensure the trials meet all relevant regulations and are Inspection Ready. Perform co-monitoring site visits as part of the sponsor oversight.
  • Co-development and review of study documents e.g., study protocol, informed consent form, monitoring guidelines, study manuals, Case Report Forms, Clinical Study Reports and regulatory authority submissions.
  • Coordinate the internal cross functional study team.
  • Supporting the development and updates of BioArctic's internal processes and working methods for the planning and execution of clinical trials.

Education
University degree in a relevant natural science subject area.

Necessary Experiences
At least 10 years of experience in clinical project/study management, preferably in international/global drug development.

Experience of sponsor oversight from planning stage to close-out, including CRO selection, management and contract and budget negotiations with CROs and other vendors as well as closure activities.

Strong project management skills (proactive, planning, organized) including experience of project managing cross functional teams in clinical development.

Experience from preparing documentation for clinical trials as well as associated regulatory documentation e.g., CSP, CSR, IB, Informed Consent Form etc.

Desirable Experiences
Experience of early development trials and clinical trials in rare diseases.

Experience of clinical operations in CNS diseases.

Necessary knowledge
In-depth knowledge of processes/regulations for the implementation of clinical trials such as ICH-GCP, Clinical Trials Regulation, 21 CFR and other relevant regulations for conducting clinical trials.

Knowledge of IND/CTA submission to FDA and other competent authorities.

Fluent in Swedish and English, both oral and written.

Desirable knowledge
Very good ability to communicate verbally and in writing.

Knowledge of regulatory requirements including IVDR.

This is a temporary assignment of 12 months, with a start date as soon as possible.

Please note, that the candidate selection is ongoing; applications may be closed earlier than the posted deadline.

Welcome with your application

This recruitment process is handled by BioArctic, and we must respectfully decline any outreach from external recruitment or staffing agencies.
BioArctic is an innovative Swedish biopharma company focusing on research into neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and ALS. BioArctic's research has resulted in the world's first fully approved disease-modifying drug against Alzheimer's disease. The company has also developed the BrainTransporter technology, that has the possibility to improve the result of treatment against diseases of the brain. BioArctic's head office is located in Stockholm Sweden, and the company has more than 130 employees.

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