Sr Clinical Study Manager
Posting ID: JP-002665591
The Sr. Clinical Study Manager manages global clinical studies for one or more product candidates, with one or more indications, from early development to regulatory approval (Phase 1-3) and beyond, to achieve a high-quality product for the marketplace and business success for company. This involves participation in all aspects of study design, execution, analysis and reporting, including critical document design (protocol, CRF, data management plan, statistical analysis plan, clinical study report), vendor selection and management, oversight of investigator selection, study conduct and site monitoring, data collection, analysis planning and reporting, managing clinical supplies, quality control, and study budget development and tracking to ensure compliance with regulatory and ICH/FDA GCP guidelines.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Contribute to the preparation for approval of Clinical Development Plans, budgets and proposed go/no-go decision criteria for one or more global development programs ensuring the needs and requirements of all regions are met.
• Manage internal resources, external partners, consultants, vendors and external budgets to ensure the timely and cost-effective implementation of the Clinical Development Plan for one or more global development programs.
• Supervise and mentor direct and indirect reports, as necessary.
• Participate in co-monitoring evaluation visits.
• Assess and recommend CROs and preferred vendors for implementation of clinical studies.
• Review and approve contracts, work orders and invoices within grant of authority.
• Coordinate and manage production of key deliverables for clinical trials, including protocols, case report forms, statistical analysis plans, data management plans and clinical study reports.
• Ensure operational execution of clinical studies within required timelines and budget, and in accordance with regulatory requirements and Standard Operating Procedures.
• Represent Clinical Development in integrated product development clinical sub-teams to ensure high scientific, ethical and regulatory standards, and expeditious registration submissions worldwide.
• Establish and maintain effective communication and collaboration with functional area peers, including basic research, manufacturing, regulatory, quality assurance, project management, and marketing, as well as thought leaders to meet program objectives and support achievement of department and corporate goals.
• All other duties as assigned.
NIAD Government, clinical project manager, budgets, finance, regulatory, Clinical trial management, Clinical trial
Top Skills Details:
NIAD Government, clinical project manager, budgets, finance, regulatory
Additional Skills & Qualifications:
EXPERIENCE & QUALIFICATIONS:
• Requires a BS or BA in a relevant scientific discipline.
• A minimum of 10 years’ relevant pharmaceutical clinical development experience in a sponsor or CRO role and at least 5 years in a clinical study management role or an equivalent combination of education and experience.
• Demonstrated experience in the development, implementation, management and completion of more than one major, global, clinical program.
• Experience in development of SOPs, CSRs, INDs, eCTDs, and other clinical, regulatory, and safety documents.
• Experience in managing staff and mentoring and developing junior staff.
• Experience in developing RFPs and selection and management of CROs/vendors.
• Knowledge of pharmaceutical business, worldwide drug development and regulatory process.
• Ability to assist in preparation of clinical development plan, clinical trial design, protocol writing, CSRs, sections for investigator brochures and essential documents.
• Expertise in clinical trial design, conduct and interpretation of scientific data.
• Strong leadership and interpersonal skills and the ability to manage and cultivate relationships and foster employee development.
• Ability to recommend/make high-level decisions and to communicate effectively on a senior management level and externally.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072