The Manager, Clinical Trial Disclosure and Transparency is responsible for executing CSL disclosure and transparency activities as directed, including clinical trials registration and summary results disclosure, in all regions across the global CSL organization according to CSL policy. He/she will manage the trial disclosure system in collaboration with the Senior Manager, Clinical Trial Disclosure and Transparency
The incumbent will also contribute to the development and maintenance of procedures and standards that will support current and future global clinical trial disclosure requirements.
1) Responsible for executing CSL clinical disclosure and transparency activities in compliance with applicable global regulations and in accordance with CSL policy and SOPs, including:
- Works cross-functionally to identify clinical trials which require registration and posting of results.
- Communicates disclosure timelines to project teams, Therapeutic Area Heads, Global Clinical Program Directors and Clinical Safety Physicians.
- Prepares and executes protocol registration and summary results posting to public registries in a timely fashion.
- Manages clinical trial disclosure system.
- Assists global project teams and functions with questions regarding public results disclosure.
- In collaboration with the Clinical Trial Disclosure and Transparency Senior Manager, assists Clinical Development Teams to develop and approve layperson summaries to patients and regulatory agencies as required
As guided, shares clinical results via the CSL corporate website as required
2) Contributes to the development of high quality clinical disclosure and transparency deliverables, processes and standards
- Provides input to regulatory compliant clinical trial disclosure and transparency processes and standards in accordance with CSL quality framework
- Works with local country affiliates to ensure consistency of information disclosed in various clinical trial registries
- Ensures consistency of information posted with publically disclosed information such as medical publications
Collects identified metrics on a regular basis and generates reports over time.
3) Provides expertise in clinical disclosure internally
- Known as an SME on registration and public disclosure of clinical trials
Develops further understanding on new clinical trial transparency requirements (EU CTR 536/2014, FDAAA801, etc) and global regulatory agency disclosure and transparency requirements (FDA, EMA, PMDA, etc)
4) Responsible for developing and maintaining collaborative relationships internally and with vendors to ensure effective and efficient working relationships and the delivery of high quality outputs that support a successful portfolio pipeline
- Maintain strong working relationships with Medical Writing to ensure quality and on time registration and disclosure deliverables
Work with vendors as required to produce high quality deliverables.
Experience and Qualifications:
Bachelors degree in a scientific/medical/pharmaceutical discipline is required. Other commensurate qualifications and/or related experience in industry considered if equivalent.
At least 3 years working in a Clinical Development and/or regulatory affairs environment is required.
Sound understanding of the clinical development process, in particular clinical trial disclosure obligations.
Working experience with international registration and results posting on clinical trial registries
Demonstrated experience in clinical trial disclosure and transparency processes and systems.
Understanding of international regulatory guidelines pertaining to clinical trial disclosure and transparency
Knowledge of ICH-GCP, awareness of clinical publication practices and standards (ie ICMJE)