Based in Basel, this position in the PDMA Regulatory Business Processes team offers the opportunity to work in a recently-established and exciting area, involving a high degree of collaboration, with the ultimate goal of furthering scientific research and analysis both within and outside of our customer.
Your role will be to manage and action data sharing requests:
- Receiving and tracking requests, originating both within and outside of our customer.
- Establishing individual needs with parties who request information.
- Managing the approval of requests, and documenting data sharing agreements.
- Communicating with a variety of stakeholders, and searching systems to source information.
- Preparing information for sharing, ensuring that patient confidentiality and commercially sensitive information remain protected.
- Sharing information and following-up with the requestor, ensuring that our customer remain informed of any research outcomes.
- An engaged, smart person, that gets things done: ability and track record, in terms of being hardworking, self-motivating and achieving results is a must. Interest in getting hands dirty, and working on actual cases – this will still be a significant part of the job.
- A teamworker and collaborator: Open, supportive of others, flexible, collaborative outlook. Will need to manage and influence many, diverse stakeholders, in a cross-functional environment. Outwards looking, and integrative.
- Rational, clear, structured and detail-oriented: Ability to quickly and clearly establish structure around problems / systems / processes / argumentation. Ability to handle both detail and big picture. Structured, thorough, accurate, consistent.
- Strong communication skills: Written, verbal and presentational, in a diverse multicultural environment. Ability to confidently represent the group. A good, empathic listener – able to understand and communicate with people having diverse perspectives.
- Maturity and ability to handle ambiguity: Calm and measured when under pressure.
- A good complement/balance for current members of the team: Do you like them? Do they bring something that we don’t have in the team at the moment? Will they challenge and stretch us in a good way?.
Successful candidates will demonstrate:
- A collaborative, supportive and engaging approach with people.
- A forwards-looking, agile, and action-oriented approach to work.
- Strong communication and organizational skills.
You will bring 5 or more years of experience in Biometrics, Operations, Clinical Science or Regulatory functions, within the Pharma industry, with knowledge of:
- Clinical trial documentation such as Protocols and Clinical Study Reports.
- Clinical trial management systems and trial-level data.
- Clinical trial databases and patient-level data.
- A Bachelors / Masters level Scientific degree.
- Minimum 5 years of experience, working within the Healthcare / Pharma environment