Global Trial Manager, Clinical Operations

Sun Pharma is the world’s fourth largest Generics Pharmacrutical 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.

Description:

Sun is seeking a Global Trial Manager, Clinical operations within its clinical development Team in Princeton, NJ.  The Global Trial Manager, Clinical Operations will report into Global Trial leader, Clinical Operations.  Under the direction of the Global Trial leader, Clinical Operations, the Global Trial Manager, Clinical Operations will assist Global Trial leader in providing global, regional or complex local management of Sun Pharmaceutical’s clinical trials.  This role will be Instrumental in providing operational oversight of assigned project(s) for end-to-end clinical trial management including start-up, execution, close-out, and study report finalization. Responsibilities include reviewing study plans and study documents, monitoring study progress and data quality and coordinating trial tasks and timelines, ensuring all teams and tasks are on track. 

Responsibilities:

Oversight of CRO / other vendors and study management-

• Oversees CRO pre-site selection and site initiation, interim close-out and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance
• Assists in the management of CROs and other vendors to ensure project requirements are met
• Ensure proper overview and communicate to teams (including on-time or high quality) of monitoring activities, data flow, data validation
• Evaluating and monitoring the project progress and resources to ensure projects are on time and within budget
• Reviewing operational aspects of trial activity and clinical protocols, providing oversight for trial implementation activities
• User of systems and business technologies to document and track study and user progress
• Assist in review of clinical protocols, amendments, informed consents, CRF/source document design, protocol specific training documentation, administrative letters etc.
• Oversee TMF management and review TMF documents as necessary
• This position requires approximately 10% travel to domestic and international locations

Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS etc.)

• Work with QA for CAPA documentation and resolution
• Assists in forecasting of IP requirement during the study and prepare IP requisition.
• Assists in preparing and obtaining approval for clinical trial budget and for any change in the budget during the study; annual forecasting and tracking of spend.
• Assist in overall project planning and execution for clinical protocols

Collaboration with cross functional teams-

• Coordinate with cross functional teams (e.g. Medical monitor, Regulatory Affairs, supply chain, statistics, Data management, QA and QC, CRO, vendors etc.)Works cross-functionally and with external vendors to proactively manage the execution of the clinical trials
• Provide administrative support around meeting management, assembly of presentations for Investigator meeting and CRO/vendor kick-off meetings as required
• Interacting with various internal and external teams to facilitate successful project completion
• Assist in managing study team meetings with both internal and external resources

Qualifications:

• Minimum 6 years clinical study management experience with at least 2 years direct multinational study management experience
• Bachelor’s level degree in life sciences, pharmacy or nursing
• 2 + years dermatology experience
• Ability to manage delegated aspects of assigned clinical trials
• Ability to manage CROs and Clinical Study vendors
• Robust understanding of ICH/GCP, and knowledge of regulatory requirements
• Proficiency in MS office including Word, Excel, PowerPoint and other applications
• Strong clinical study/project management skills
• Outstanding communication skills, both verbal and written
• Ability to work independently and prioritize duties
• Understanding of Electronic Data capture (EDC), CDMS, IRT etc.

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.