Title: Global Clinical Trial Management Lead

Sun Pharma is the world’s fourth largest Generics Pharmaceutical Company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. This position is located in Princeton, New Jersey. Sun employs a HYBRID work schedule: 3 days in office; 2 days remote.

Summary

The Global Trial Management Leader (GTML) provides guidance and oversight to Global Trial Leaders (GTLs) responsible for global, regional or complex local management of clinical trials. Leader in the Global Trial Management branch and member of the Global Clinical Operations Leadership team

Responsibilities

• Operational oversight of GTLs assigned to project(s) for end-to-end clinical trial management including CRO selection for outsourced trials, start-up, execution, close-out, analysis and reporting.

• Strategic decisions for CRO identification and selection through RFP process

• Create a partnership with CRO and other vendors

• Influence CRO study team to effect change when necessary

• Recognize and escalate poor CRO performance

• Define and drive program timelines and milestones with Project Management

• In collaboration with relevant cross-functional team members, evaluates, refines and makes recommendations for various clinical operational aspects of program execution

• Prepare & obtain approval for clinical program budget and for any change in the budget during the study; full awareness of annual forecasting and tracking of spend.

• Participate in vendor selection. Oversee & assess vendor performance.

• Plan program activities and timelines and share with stakeholders, set up tracking tools for assigned programs & assess progress as per pre-set timelines.

• Meet investigators and key opinion leaders for assigned trials.

• Coordinate with cross functional groups for required deliverables.

• Provide status update to stakeholders as per program requirement.

• Review of protocols and provide operational input, vendor proposals and other documents and lead initiatives as assigned by the function head .

• Coordinate with internal cross functional teams (DM, BIOS, MW, Reg Affairs, PMO and others) and the CRO and ensure completion of the study within timeline and with expected quality

• Perform enrolment booster visits

• Implement risk Mitigation strategies along with CROs

• Line Management for assigned resources. Properly resource the programs.

• Recruit and retain top industry talent

• Complete assigned trainings & maintain updated personal training file.

Qualifications

• Bachelor’s Degree (Advanced Degree preferred )
• 15 years of relevant study management (15 in Pharma sponsor; 18 in CRO);
• 7 years of people management

This position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.