Beschreibung
Manager Clinical Trial Disclosure & Transparencyis responsible for providing operational support and managing activities related to global Clinical Trial Disclosure and Data Transparency. This role will serve as a subject matter expert and will partner with cross-functional teammates and stakeholders to ensure compliance with the legal and regulatory requirements for disclosure and transparency. Support of clinical trial registry activities, lay language results summaries, document redaction, and clinical data sharing may be in scope.
Job duties.
- Ensure Compliance with all global applicable laws, regulations and internal policies in regard to Clinical Trial Disclosure
- Lead different disclosure activities related to Cinical Trails
- Pounced knowledge of PharmaCM Disclosure system is a must
- Administrated ClinicalTrials.gov and EudraCT accounts sponsored clinical trials
- Deliver updates for all posted sponsored clinical trials
- Act pro-actively on any Clinical Trial Disclosure topics including but not limited to Responsible Data Sharing, Lay Patient Summary or Policy 0070 issues to ensure compliance
- Provide expert support for internal stakeholders
- Act as Subject Matter Expert for a respective Clinical Trial Disclosure training
- Actively participate in internal and external continuous improvement activities
- Accountable for management of the vendor/s responsible for outsourced activities related to Clinical Trial Disclosure
- Support internal audit and inspection activities as required
- Provide on the regular basis reports of metrics related to tracking and monitoring clinical trial Disclosure activities
Profil:
- Bachelor in Biotechnology or a related field of study
- Experience in the biotechnology/pharmaceutical industry
- Minimum 5 years’ experience in Transparency, Clinical Science, Clinical Operations, or Medical writing
- Experience in Vendor Management
- Minimum 3 years’ experience in clinical trial disclosure
- Demonstrated ability to learn global regulatory requirements and other policies (eg. ICMJE) related to clinical trial disclosure
- Understands the clinical drug development process, including clinical trial design, operations and results analysis
- Strong organizational, planning and project management skills, along with initiative and ability to work independently and as part of a team
- Outstanding oral and written communication skills
- Flexible mindset