Search Jobs
Planet Pharma
https://cdn.haleymarketing.com/templates/63514/logos/square.png
https://www.planet-pharma.com
https://www.planet-pharma.com
true
Pay range: 66-76/hr
*depending on experience
Job Description:
The Manager, Clinical Trial Disclosure and Transparency is responsible for executing disclosure and transparency activities as directed, including clinical trials registration and summary results disclosure, in all regions across the global organization according to 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.
This role, within the Office of the CMO, operates within a global matrix organization and is responsible for active collaboration with stakeholders within R&D and potentially the wider business, including Clinical Development and Medical Writing, Commercial, Medical Affairs, Legal and Communications to provide aligned transparency and disclosure deliverables and procedures.
Responsible for executing clinical disclosure and transparency activities in compliance with applicable global regulations and in accordance with 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 corporate website as required
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 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.
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)
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.
The ideal candidate possesses the following competencies:
Personal and interpersonal
• Is customer focused
• Is easy to approach and to talk to
• Demonstrates appropriate values and ethics
• Takes responsibility for own behavior
• Relates well to all kinds of people
• Is an attentive and active listener
• Is seen as a (global) team player and is cooperative
Global
• Can develop cross cultural agility. Open to the need for flexibility and can engage with locals to get things done.
Organizational
• Is able to write clearly and succinctly in a variety of communication settings and styles
Strategy
• Has the functional and technical knowledge and skills to do the job at a high level of accomplishment
• Can learn new skills and knowledge
Energy and drive
• Is action oriented and enjoys working hard
• Pursues everything with energy, drive and the need to finish
Operations
• Can orchestrate multiple activities at once to accomplish a goal, arranges information and files in a useful manner
• Able to clearly identify the most important priorities and focus energies accordingly
• Is a consistent communicator, providing timely information allowing accurate decisions
• Can critically analyze and interpret complex scientific content
Minimum Required Qualifications:
• Bachelor’s 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)
*CO/NYC candidates might not be considered
Clinical Trial Disclosure & Transparency Manager
Posted: 05/08/2025
2025-05-08
2025-06-11
Employment Type:
Contract
Job Category: Clinical Development and Operations
Job Number: 619436
Is job remote?: Yes
Country: United States
Job Description
Pay range: 66-76/hr
*depending on experience
Job Description:
The Manager, Clinical Trial Disclosure and Transparency is responsible for executing disclosure and transparency activities as directed, including clinical trials registration and summary results disclosure, in all regions across the global organization according to 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.
This role, within the Office of the CMO, operates within a global matrix organization and is responsible for active collaboration with stakeholders within R&D and potentially the wider business, including Clinical Development and Medical Writing, Commercial, Medical Affairs, Legal and Communications to provide aligned transparency and disclosure deliverables and procedures.
Responsible for executing clinical disclosure and transparency activities in compliance with applicable global regulations and in accordance with 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 corporate website as required
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 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.
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)
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.
The ideal candidate possesses the following competencies:
Personal and interpersonal
• Is customer focused
• Is easy to approach and to talk to
• Demonstrates appropriate values and ethics
• Takes responsibility for own behavior
• Relates well to all kinds of people
• Is an attentive and active listener
• Is seen as a (global) team player and is cooperative
Global
• Can develop cross cultural agility. Open to the need for flexibility and can engage with locals to get things done.
Organizational
• Is able to write clearly and succinctly in a variety of communication settings and styles
Strategy
• Has the functional and technical knowledge and skills to do the job at a high level of accomplishment
• Can learn new skills and knowledge
Energy and drive
• Is action oriented and enjoys working hard
• Pursues everything with energy, drive and the need to finish
Operations
• Can orchestrate multiple activities at once to accomplish a goal, arranges information and files in a useful manner
• Able to clearly identify the most important priorities and focus energies accordingly
• Is a consistent communicator, providing timely information allowing accurate decisions
• Can critically analyze and interpret complex scientific content
Minimum Required Qualifications:
• Bachelor’s 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)
*CO/NYC candidates might not be considered
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
Share This Job:
Related Jobs:
There are currently no related jobs. Please sign up for Job Alerts.
Loading...
Login to save this search and get notified of similar positions.
About King of Prussia, PA
Discover exciting job opportunities in the vibrant area around King Of Prussia, Pennsylvania! Home to the iconic King of Prussia Mall, the largest shopping mall on the East Coast, this region offers much more than just great shopping. With its close proximity to Philadelphia, the City of Brotherly Love, and convenient access to major highways, King Of Prussia provides a perfect blend of suburban charm and urban convenience. Explore career options in this dynamic region, known for its rich history, diverse dining scene featuring local favorites like Philly cheesesteaks, and cultural attractions such as the Valley Forge National Historical Park. Join a bustling community that boasts top-notch art galleries, performance venues like the Kimmel Center, and sports teams like the Philadelphia Eagles. Take the next step in your career and embrace the endless possibilities that King Of Prussia, Pennsylvania, has to offer!
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.