Lead Indian Operations to reach growth and profit targets.
Project Oversight: Oversee country project operations in India to ensure clinical trials are performed on schedule, within budget and meet all quality and regulatory requirements. Participates in project health meetings and reviews project health reports to remain informed and aware of project status, issues and overall health for projects conducted within assigned geography(s). Might act as project executive and maintains executive level relationships with Sponsor(s).
Business Operations: Manages with appropriate approvals from Biorasi HQ the office space, accounting, local licenses, other filings, local expense payments, local financial performance. Supports Biorasi Legal with the standardization of contracts for assigned geography.
Resource Management: Supports the standardization of offer letters and establishes market rate salary/rate guidelines for assigned geography(s). Manages assigned geography(s) staffing needs and provides support and input to branch heads on vacation approvals, on boarding and off boarding logistics, and HR/payroll for staff in assigned geography.
Employee Development: Works with Branch Heads and Training Department to ensure staff are receiving required training and recommend and lead localized training as needed for staff in the assigned geography. Support and provide feedback and recommendations to Branch Heads, on KPIs, performance progress, salary adjustments and promotions for staff located in assigned geography.
Collaborate with Branch Heads and Geographic Heads and others to optimize project operations and delivery and to support complex, high-visibility process innovative projects (to include but not limited to Talos, Optimization of India Operations etc.).
Lead the Cross-Functional Study Teams in India as needed; frequent cross-functional interactions with internal and external personnel (e.g., Regulatory Affairs, investigators, vendors, etc.).
Participates in project acquisition activities; provides input on client proposals, presentations; scope; budgetary estimates; and participates in bid defense meetings.
Other duties as assigned.
Qualifications and Experience Required:
Medical Doctor is highly preferred.
Master’s Degree in Biomedical Sciences and related scientific discipline.
Strong experience leading operations in the life sciences industry
10+ years of supervisory or management experience.
Strong leadership, planning, and problem-solving skills.
Excellent organizational, multi-tasking and time management skills.
Effective business skills for interactive situations with peers and clients.
Sound knowledge of the clinical trial life cycle.
Excellent verbal and written communications skills in English.
Knowledge of FDA, CDSCO regulations and ICH GCP guidelines.