Clinical Trial Manager

SDI International Corp.; United States; On-site; USD 100,000 - 135,000; Full time

Job summary

An established industry player is seeking a Clinical Trial Disclosure and Transparency Manager to oversee the execution of disclosure activities for clinical trials. This role involves managing the trial disclosure system and collaborating with various stakeholders to ensure compliance with global regulations. The ideal candidate will have a strong background in clinical development and regulatory affairs, with a focus on transparency and disclosure processes. Join a dynamic team where your expertise will contribute to high-quality clinical trial deliverables and support a successful portfolio pipeline.

Qualifications

• 3+ years in Clinical Development or regulatory affairs required.
• Experience with clinical trial disclosure obligations essential.

Responsibilities

• Execute clinical trial registration and results posting.
• Manage trial disclosure system and collaborate with project teams.

Skills

Clinical Trial Disclosure

Regulatory Affairs

Cross-Functional Collaboration

Communication Skills

Project Management

Education

Bachelor’s degree in a scientific/medical/pharmaceutical discipline

Job description

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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

• 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)

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Information Technology

• Industries

  IT Services and IT Consulting

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