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Senior Manager, Clinical Outsourcing
2 months ago
Sun Pharma is the world’s fourth largest specialty generics 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.
Description:
Sun is seeking a Sr. Manager, Clinical Outsourcing within its Clinical Outsourcing Team in Princeton, NJ. The Sr. Manager, Clinical Outsourcing will report into Sr. Director, Clinical Outsourcing. Under the direction of the Sr. Director, Clinical Outsourcing, the Senior Manager, Clinical Outsourcing will lead and manage the clinical trial outsourcing, vendor selection and contract negotiation, vendor management, and reporting process for Sun Pharmaceutical’s clinical development programs. This role will be Instrumental in the management of external partnership outcomes for clinical trials, including coordination and management of service providers and other outsourcing needs. Responsibilities include clinical CRO/vendor identification, RFI/RFP development and execution, vendor selection, contract negotiations, budget management and service provider performance metrics development and tracking.
Responsibilities:
35% Vendor selection and contract negotiation:
Guides project teams through the outsourcing process and gives appropriate suggestions and advice on the best approach / best practices
Guides and participates in the evaluation, selection, and negotiation of contracts for assigned studies/programs.
Works with Project Managers and Project Teams to develop RFPs.
Works with Project Managers and Project Teams for all operational, scheduling, project budget and cost-saving considerations for assigned studies/programs.
Liaises with project teams to develop the Statement of Work (SOW) for each contract; coordinates the SOW review and finalization process.
Negotiates new and amended work specifications, budgets, payment schedules, relationship management plans, and other documents that control the activities and performance of contract service providers.
25% Vendor management: 15 – 25 Vendor per study
Participates in scheduling, organizing, and facilitating kickoff meetings with vendors.
Participates team meetings with vendors.
Supports the project teams to assure the quality and timeliness of deliverables through outsourcing.
Monitors and manages relationships with contracted vendors; facilitates the resolution of issues and conflicts.
Supports organizational governance activities with vendors.
Works with Project Teams to ensure outsourced clinical trial activities meet quality standards and expectations and adheres to applicable Corporate SOPs, WPs, policies, guidelines, and regulations.
Ensures smooth and effective communication between the vendors and the company.
Ensures Vendors/CROs are accountable and Identifies issues and develop solutions
Facilitates the closure of each study/contract with the vendor, including a mutual assessment of performance.
30% Support Outsourcing Team
Locate Statement of Work (SOW) for each study level agreement; save the working documents as well as final contracts to the Clinical Outsourcing folder.
Ensure consistent naming convention
Review CRO Contract & populate category spend to allow for analysis
Ability to Liaise with project teams, CROs and Vendors
Ability to search Contract Management System
Create Vendor Contract Trackers for each study and update with contract data and terms
Collect and analyze data from CRO contracts
Setup Outsourcing Onboarding guidelines.
Support the development of templates and save to Outsourcing folders.
Setup cost-saving excel file.
Assist with creating clinical trial budgeting models and what-if scenarios for future trials
Assist with FP&A needs related to clinical vendors, including annual budgeting, periodic forecasting, and monthly budget vs. actual analysis
10% Cross-Functional Support
Assist with creating clinical trial budgeting models and what-if scenarios for future trials
Assist with FP&A needs related to clinical vendors, including annual budgeting, periodic forecasting , and monthly budget vs. actual analysis
Core technical skillsDemonstrated expertise in forecasting, budgeting, data analytics, modeling, and process improvement design.
Pharmaceutical portfolio experience across teams, collaborating with Clinical Operations, Cost Management, Finance and Procurement functions
Vendor and or clinical CRO oversight experience, ensuring execution within budget, on time, and of the highest quality
Must have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sites
Positive management style, combined with superior communication skills and unwavering ethics and integrity
Strong interpersonal skills with demonstrated ability to connect, collaborate and build relationships across all levels and functions and establish credibility with leaders and key external stakeholders
Strong oral and written communication skills with ability to communicate effectively at all levels and present complex and/or new ideas both internally and with external stakeholders
Extensive knowledge of GCP and ICH principles of clinical trial conduct
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Microsoft Project a plus.
Core leadership behavioral skills/ leadership skills (examples below)Leadership Skills: Strong leadership and team management skills, with a track record of effectively leading cross-functional teams.
Strategic Thinking:
Analytical Skills:
Problem-Solving: Strong problem-solving and decision-making capabilities, with the ability to navigate complex challenges.
Industry Awareness: Stay current with industry trends, emerging therapies, and advancements in clinical trial methodologies.
Interpersonal Skills: Collaborative and able to build strong relationships with internal teams and external partners.
Contributes to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.
Qualifications:
BA or MS in relevant discipline
Minimum of 5 years clinical outsourcing experience
Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and is be eligible for a company vehicle and incentive bonus compensation. 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.
