Senior Manager, Clinical Outsourcing Position Available In Mercer, New Jersey

Job Description:

Sun Pharma is the world’s fourth largest specialty genericscompany with presence in Specialty, Generics and ConsumerHealthcare products. Supported by more than 40 manufacturingfacilities, we provide high-quality medicines, trusted byhealthcare professionals and patients, to more than 100 countriesacross the globe. Over the last two decades, Sun Pharma hasestablished itself as a leading player in the generics market inthe U.S., and we are rapidly ramping up our presence in thespecialty branded market with a focus on dermatology, ophthalmologyand onco-dermatology. Sun is seeking a Senior Manager, ClinicalOutsourcing within its Clinical Outsourcing Team in Princeton, NJ.The Senior Manager, Clinical Outsourcing will report into Sr.

Director, Clinical Outsourcing. Under the direction of the SeniorDirector, Clinical Outsourcing, the Senior Manager, ClinicalOutsourcing will lead and manage the clinical trial outsourcing,vendor selection and contract negotiation, vendor management, andreporting process for Sun Pharmaceutical’s clinical developmentprograms. This role will be Instrumental in the management ofexternal partnership outcomes for clinical trials, includingcoordination and management of service providers and otheroutsourcing needs. Responsibilities include clinical CRO/vendoridentification, RFI/RFP development and execution, vendorselection, contract negotiations, budget management and serviceprovider performance metrics development and tracking.

Responsibilities:

35% Vendor selection and contract negotiation:

Guides project teams through the outsourcing process and givesappropriate suggestions and advice on the best approach / bestpractices Guides and participates in the evaluation, selection, andnegotiation of contracts for assigned studies/programs. Works withProject Managers and Project Teams to develop RFPs. Works withProject Managers and Project Teams for all operational, scheduling,project budget and cost-saving considerations for assignedstudies/programs. Liaises with project teams to develop theStatement of Work (SOW) for each contract; coordinates the SOWreview and finalization process. Negotiates new and amended workspecifications, budgets, payment schedules, relationship managementplans, and other documents that control the activities andperformance of contract service providers. 25% Vendor management:15 – 25 Vendor per study Participates in scheduling, organizing,and facilitating kickoff meetings with vendors. Participates teammeetings with vendors. Supports the project teams to assure thequality and timeliness of deliverables through outsourcing.

Monitors and manages relationships with contracted vendors;facilitates the resolution of issues and conflicts. Supportsorganizational governance activities with vendors. Works withProject Teams to ensure outsourced clinical trial activities meetquality standards and expectations and adheres to applicableCorporate SOPs, WPs, policies, guidelines, and regulations. Ensuressmooth and effective communication between the vendors and thecompany. Ensures Vendors/CROs are accountable and Identifies issuesand develop solutions Facilitates the closure of eachstudy/contract with the vendor, including a mutual assessment ofperformance. 30% Support Outsourcing Team Locate Statement of Work(SOW) for each study level agreement; save the working documents aswell as final contracts to the Clinical Outsourcing folder. Ensureconsistent naming convention Review CRO Contract & populatecategory spend to allow for analysis Ability to Liaise with projectteams, CROs and Vendors Ability to search Contract ManagementSystem Create Vendor Contract Trackers for each study and updatewith contract data and terms Collect and analyze data from CROcontracts Setup Outsourcing Onboarding guidelines. Support thedevelopment of templates and save to Outsourcing folders. Setupcost-saving excel file. Assist with creating clinical trialbudgeting models and what-if scenarios for future trials Assistwith FP&A needs related to clinical vendors, including annualbudgeting, periodic forecasting, and monthly budget vs. actualanalysis 10% Cross-Functional Support Assist with creating clinicaltrial budgeting models and what-if scenarios for future trialsAssist with FP&A needs related to clinical vendors, includingannual budgeting, periodic forecasting , and monthly budget vs.actual analysis Core technical skills Demonstrated expertise inforecasting, budgeting, data analytics, modeling, and processimprovement design. Pharmaceutical portfolio experience acrossteams, collaborating with Clinical Operations, Cost Management,Finance and Procurement functions Vendor and or clinical CROoversight experience, ensuring execution within budget, on time,and of the highest quality Must have extensive experience managingCROs, central laboratories, and other clinical study vendors,including trial sites Positive management style, combined withsuperior communication skills and unwavering ethics and integrityStrong interpersonal skills with demonstrated ability to connect,collaborate and build relationships across all levels and functionsand establish credibility with leaders and key externalstakeholders Strong oral and written communication skills withability to communicate effectively at all levels and presentcomplex and/or new ideas both internally and with externalstakeholders Extensive knowledge of GCP and ICH principles ofclinical trial conduct Strong computer skills with demonstratedexperience in working with the Microsoft suite of programs (Word,Excel, PowerPoint, and Outlook). Microsoft Project a plus.

Qualifications:

BA or MS in relevant discipline Minimum of 5 yearsclinical outsourcing experience Actual base compensation may varybased on a number of factors, including but not limited togeographical location and experience. In addition, this position ispart of the Annual Performance Bonus Plan, and is be eligible for acompany vehicle and incentive bonus compensation. Employees areeligible to participate in Company employee benefit programs whichinclude medical, dental and vision coverage; life insurance;disability insurance; 401(k) savings plan; flexible spendingaccounts; and the employee assistance program. Employees alsoreceive various paid time off benefits, including vacation time andsick time. The compensation and benefits described above aresubject to the terms and conditions of any governing plans,policies, practices, agreements, or other materials or documents asin effect from time to time, including but not limited to terms andconditions regarding eligibility. If hired, employee will be in an”at-will position” and the Company reserves the right to modifybase salary (as well as any other discretionary payment orcompensation program) at any time, including for reasons related toindividual performance, Company, or individual department/teamperformance, and market factors. The preceding job description hasbeen designed to indicate the general nature and level of workperformed by employees within this classification. It is notdesigned to contain or be interpreted as a comprehensive inventoryof all duties, responsibilities and qualifications required ofemployees as assigned to this job. Nothing herein shall precludethe employer from changing these duties from time to time andassigning comparable duties or other duties commensurate with theexperience and background of the incumbent(s). We provide equalemployment opportunities for all current employees and applicantsfor employment. This policy means that no one will be discriminatedagainst 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 orany other basis prohibited by law.