Manager, Clinical Outsourcing
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes website at www.alkermes.com .
POSITION SUMMARY : Responsible for supporting Clinical Outsourcing function, providing oversight and guidance to the Clinical Outsourcing team in support of the clinical project outsourcing plans, contract management, and CRO Sunshine reporting management for Clinical Operations. Manager must possess working knowledge of clinical trials, pharmaceutical industry related processes, and outsourcing activities in support of clinical development function: Including: CRO/vendor RFPs and selection processes, database management, contract processing/management, and Sunshine Act reporting.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Clinical Outsourcing Management:
* Provide managerial support to Outsourcing Team and guidance to improve streamlining Outsourcing functionality and processes.
* Serve as a lead outsourcing representative on applicable cross-functional clinical study and study start up teams.
* Manage and maintain effective partnerships with contracted suppliers and drive supplier compliance by ensuring that standardized contracting practices are applied and maintained across all relevant providers
* Work closely with the Legal Department to determine vendor prioritization and assist with administrative preparation of contracts, specifically study requirements for specific contracts or work orders for review/negotiation by Legal Department
* Ensure vendors of outsourced clinical trial activities meet Alkermes quality standards and expectations and adhere to applicable Corporate SOPs, policies, guidelines, and regulations
* Establish and standardize clinical contracting practices, systems, and tools, in conjunction with the Legal Department, to support clinical studies in order to meet company goals and objectives and ensure providers continue to meet outsourcing expectations
* Develop, execute, and manage source plans by leading cross-functional teams to develop value enabling category sourcing strategies that maximize opportunity and mitigate supply risk
* Initiate and lead sourcing initiatives, RFx bids and analysis, and supplier evaluation and selection. Create supplier balanced scorecards to continuously measure, calibrate, and improve supplier relationships and performance
Compliance Reporting: Federal Physician Payments Sunshine Act ('Sunshine Act')
* Provide oversight and management of CRO partner Sunshine Act reporting to ensure that all reports are received and validated in Alkermes standard format.
* Manage the CRO Sunshine Act reporting process.
* In conjunction with the Compliance department, provide subject-matter expertise in Sunshine Act reporting requirements to identify, collect, validate CRO reporting on an ongoing basis.
* Works closely with Senior Clinical Trial Associate and Compliance department to coordinate compliance data in support of Sunshine Act State laws and restrictions, transparency and public disclosure.
* Provides assistance and support in collection of data and validates data from CRO/3 rd parties related to aggregate spend reporting used to prepare and report federal filings.
Clinical Systems Management:
* Works cross-functionally with Legal Compliance in support of development, streamlining Sunshine Act reporting.
* Support efforts to create and implement outsourcing processes and reporting as required. (i.e. Database systems design, contract management, Sunshine reporting, other)
* Develops Excel templates for Sunshine Act
* Provide oversight to Senior Clinical Trial Associate in developing automated systems for improved workflow.
EDUCATION/SKILLS AND EXPERIENCE REQUIREMENTS:
* Science background BS or healthcare degree or diploma preferred
* Experience in clinical or pharmaceutical/biotech or academic setting
* Experience contract negotiations
* Knowledge of Physician Financial Transparency Reports (Sunshine Act)
* Ability to work to work across multiple functions
* Ability to review complex and disparate data in a clear and concise manner
* Ability to learn and work autonomously
* Excellent interpersonal, organizational and multi-tasking skills.
* Ability to interface with outside counsel, vendors, collaborators, all internal departments and all levels of management
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.