Manager, Clinical Science (Neuropsychiatry) managing study execution and collaboration with cross-functional teams at Johnson & Johnson. Ensuring compliance and quality in clinical trial protocols and reporting.
Responsibilities
Support the execution of clinical strategies for clinical trial protocols of the clinical development plan, ensuring compliance with scientific, organizational and regulatory standards
Support end-to-end delivery of clinical trial protocols, including study design, initiation, medical data monitoring, data dissemination and closeout activities
Co-manage and coordinate trial activities with internal, cross-functional and external (e.g., vendors, clinical sites) partners to ensure timely execution of clinical trials and to ensure the quality and integrity of data is critical to the evaluation of study endpoints
Support providing training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes
Support the review, interpretation, and reporting of clinical trial data, assisting with ensuring accuracy and integrity for health authority submissions
Contribute to the preparation of documents for reporting clinical trial data (e.g. clinical study reports, patient narratives, investigator brochures, and periodic safety updates)
Contribute to the medical data monitoring activities in partnership with Study Responsible Scientist and Study Responsible Physician, including the evaluation, documentation, and reporting of ongoing clinical trial data per defined medical data review plan
Contribute to process improvements and implementation of best practices in clinical trial execution
Collaborate with cross-functional partners to support clinical strategies with overall product development goals
Contributes to the preparation and presentation of the results of clinical research in internal department/ management meetings
May also support the preparation of materials for external expert advisors
Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO)
Requirements
A minimum of a bachelor’s degree in a scientific or related discipline is required
An advanced degree (e.g., MS, PharmD, PhD) is preferred
Requires a minimum of 3 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO, or equivalent
Research and development experience in neuropsychiatry preferred
Understanding of clinical development processes, including trial design, protocol development, data analysis, regulatory guidelines, Good Clinical Practice (ICH GCP), and study execution
Proven ability to interpret scientific literature and apply findings strategically within clinical projects
Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint, and familiarity with generative artificial intelligence and clinical trial management software are advantageous
Excellent written and verbal communication skills in English; ability to effectively present information to the stakeholders
Strong interpersonal skills with a collaborative approach to working within cross-functional and global matrix teams
Strong organizational skills with the ability to multi-task and prioritize assignments
Proven analytical and problem-solving capabilities, with a detail-oriented mindset
Ability to proactively identify study level issues/discussions that require escalation
Ability to handle study projects to overcome delays and obstacles to meet deadlines
Strong project and time management skills
Willingness to travel domestically and internationally, approximately 10%, as required by project needs
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