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Manager, Clinical Development (Onsite)
Lead sponsored and investigator-initiated clinical trials for SERB Pharmaceuticals, supporting studies for medicines addressing rare and urgent conditions.
विवरण
- Oversee company-sponsored and investigator-initiated studies in line with company SOPs and applicable regulations
- Ensure assigned clinical research projects follow approved protocols, Good Clinical Practice standards, and relevant regulations
- Manage outsourced activities, service providers, and contractor relationships through appropriate vendor oversight
- Prepare study materials such as synopses, protocols, informed consent forms, and study plans
- Develop clinical study budgets and oversee delivery within approved financial parameters
- Obtain required regulatory documentation from study sites and maintain complete study files in accordance with GCP and SOP requirements
- Review and update standard operating procedures when needed
- Partner with legal teams and study sites to negotiate contracts for investigator-initiated research
- Stay informed about FDA requirements, Good Clinical Practice, and ICH guidelines
- Maintain ethical and professional standards in all interactions while reflecting BTG values
- Complete additional clinical-function assignments from the Line Manager
आवश्यकताएँ
- Bachelor’s degree or higher in a health-related discipline
- At least three years of direct clinical trial experience within a CRO or research-focused organization
- Experience with in-vitro diagnostic studies is advantageous
- Experience working in the European Union is advantageous
- Ability to work independently with confidence and collaborate effectively within a team
- Understanding of clinical research activities from Phase I through regulatory submission
- Strong written and verbal communication skills for conveying complex information
- Experience managing contracts and timelines is preferred
- Highly organized with strong interpersonal skills
- Positive, adaptable approach with the ability to coordinate study activities across staff levels
- Capacity to manage competing priorities across multiple clinical trials
- Independent judgment to evaluate clinical situations and recommend appropriate solutions
- Ability to establish baseline targets, monitor trends, and implement mitigation plans
- Familiarity with fundamental data-processing activities, including electronic data capture
- Working knowledge of current ICH Good Clinical Practice guidelines
लाभ
- Vacation, personal, and sick leave
- 15 company-paid holidays
- Medical, dental, vision, and other voluntary benefit options
- Paid parental leave
- Tuition assistance
- Discretionary bonus program
- 401(k) plan with a dollar-for-dollar company match on contributions up to 6% of pay
- Safe-harbor 401(k) match that is immediately vested
- Discretionary 401(k) match of up to 4% of pay, vesting at 20% annually over five years
- Competitive compensation and benefits packages
- Supportive culture centered on collaboration
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