Manager, Clinical Operations, D&I

Descrizione del lavoro

We are seeking a detail-oriented and analytical Clinical Trial Education and Literature Review Specialist to support the development and submission of clinical trial education materials to the Promotional Review Committee (PRC) and Subject Recruitment Material (SRM). This role is also responsible for conducting comprehensive literature reviews to assess the landscape of new and emerging medical indications. The ideal candidate will work closely with cross-functional teams, including medical affairs, regulatory, and marketing, to ensure that all materials are accurate, compliant, and aligned with the latest medical research.

Responsibilities:

• Develop, organize, and submit clinical trial education materials to the Promotional Review Committee (PRC) and/or Subject Recruitment Materials (SRM) for review and approval, ensuring compliance with regulatory and company guidelines.
• Provide ongoing support during the PRC and SRM review processes, addressing feedback, revising materials, and ensuring timely approval.
• Collaborate with cross-functional teams (Clinical Development, Clinical Operations, Medical Affairs, Regulatory, Marketing, Public Affairs, etc.) to ensure educational materials align with clinical trial objectives and reflect the latest medical information.
• Monitor and stay current on industry trends, new therapies, and scientific advancements that may impact clinical trial materials or strategic positioning.
• Synthesize complex medical and scientific information into clear, concise educational content for internal and external audiences.
• Assist in the development of communication strategies that effectively educate healthcare professionals about clinical trials, investigational products, and new medical indications.
• Ensure all educational materials are updated and consistent with the latest clinical trial data and regulatory requirements.
• Maintain a comprehensive database of clinical trial education materials and literature review findings for easy access and future reference.
• Travel is required.

Basic Qualifications:

• Bachelor's degree and 8 years of experience, OR Master's degree and 6 years of experience, OR PhD degree and 3 years of experience.
• Experience in developing RFPs and selection and management of vendors.

Preferred Qualifications:

• Excellent interpersonal skills and demonstrated ability to lead
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Strong communication and influence skills and the ability to create a clear sense of direction is necessary.
• Ability to write action plans, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
• Ability to examine functional issues from a broader organizational perspective.
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.