Job Description
Primary Function of Position:
The Future Forward Global Clinical Research Manager will be a pivotal leader in helping shape the clinical strategy and guiding the design of clinical studies and building strategic clinical evidence to drive product innovation and development. This role focuses on leveraging clinical data and insights to inform product design and development, ensuring that new medical technologies are optimized for patient outcomes and regulatory success. The ideal candidate has deep expertise in translating clinical research insights into strategic product decisions and a strong background in developing clinical protocols for novel technologies.
Roles and Responsibilities:
1. Clinical Trial Design, Development and Management:
* Cross-functional collaboration with key internal and external stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision.
* Oversight of study conduct and execution including data management, including direction and support for clinical research organizations (CROs), clinical research associates (CRAs), clinical trial assistants (CTAs).
* Oversight and development of all study materials including but not limited to protocols, informed consent, data collection forms, and study binders for all Company sponsored trials maintaining all global GCP requirements.
* Responsible for driving the progress of the trial during site selection, site start-up, and through enrolment and follow-up.
* Partnership and guidance to the study monitors about monitoring needs and oversee compliance work on the study.
* Manage Future Forward clinical research activities, including planning, execution, site selection, patient recruitment, and document creation (protocols, case report forms, informed consents, clinical trial agreements, study reports).
* Ensure Future Forward clinical studies are conducted on schedule, within budget, and in compliance with quality standards.
* Provide input to Product Development based on patient risks and clinical data.
* Serve as a liaison with research sites to ensure study compliance and progress.
* Collaborate with internal stakeholders, investigators, and KOLs to develop and review study designs, protocols, and initiatives.
* Perform site qualification, initiation visits, and audits, ensuring sponsor readiness.
* Negotiate contracts and budgets with vendors and sites, in partnership with legal and management.
* Track study progress, provide status reports, and manage site payments and financial tracking tools.
* Support study start-up, approvals, and site monitoring.
* Work with biostatisticians on data analysis, clinical study reports, and scientific publications.
* Organize study meetings and mentor junior team members.
* Ensure compliance with corporate SOPs, GCP, and regulatory guidelines.
1. Evidence Generation:
* Build and maintain positive relationships with key opinion leaders, medical advisors, and clinical leaders.
* Collaborate with cross-functional teams to understand market trends and align clinical activities with Future Forward business goals.
* Assist in preparing manuscripts, abstracts, and presentations for scientific meetings and publications.
* Collaboration on evidence generation strategies and execution.
2. Post-Market Surveillance:
* Support post-market research and regulatory submissions, addressing regulatory questions and ensuring clinical study compliance.
* Contribute to regulatory processes related to adverse events, product complaints, risk assessments, and recalls.
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