Sepracor
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Marlborough,
MA
To provide outsourcing coordination (Contract Management), communication and escalation support (Vendor Management) and Financial Management (invoicing, accrual and forecast) support for current and planned clinical studies and related activities. Coordinate all outsourcing activities under the supervision of Senior Director, Clinical Outsourcing. Apply complete understanding and application of industry principles, concepts, practices and standards. Provide regular communication with respective area management, review of interdependent timelines and financial requirements and providing strategic recommendations (solutions) to the teams.
This position will have a direct impact on the outsourcing budget of the various functions supporting programs within a TA and functional areas. This position will be critical to ensure timely completion of clinical programs by providing strategic use of outside vendor services and temporary employees. The position serves to proactively identify competing priorities and outsourcing services. The development activities to be outsourced are on the critical path of NDAs or Health registration dossiers.
Essential Functions 1. Manage day-to-day outsourcing activities - Including leading all sourcing activities in vendor selection proceedings (RFIs, RFPs, evaluation and selection) for Clinical Outsourcing. Contract types include: CRO contracts and change orders, MSAs, CDAs, Consulting Agreements, Business Term Agreements, etc. Provide financial controls by negotiating budget for new and amended contracts. Participate in study team meetings and other meetings to review the status of planned, ongoing and fully executed trials with Product Development, Clinical Operations and Biostatistics and Data Management (BDM). Participation in these reviews will focus on timeline and milestone management of activities, as they relate to the executed contract; review of budget (forecasted, contracted, spent and accrued), identification of critical issues and potential resolutions in contract lifecycle management. Review and analyze activities across studies/programs and look for areas of conflict within or between studies/programs and teams. Responsible and accountable for the full lifecycle of contracts (new and change orders), including related financial terms and proactive issue resolution. (35%)
2. Acts as CRO liaison (main point of contact) for TA provider(s) and/or a functional area provider(s) in clinical operations contractual and issue resolution. Lead Sponsor / CRO interactions and interventions when barriers cannot be overcome within the team. Identify root cause, resolve issue without creating any lingering hard feelings between Sponsor and CRO. Act as the main point of contact and administrative lead, for the Joint Operational Committee, within the Vendor governance structure for the TA/Functional area provider including coordination of meetings, agenda, collection of issues, analyzing and assessing trends for review by the overall team. Act as a conduit for more strategic use of vendors and facilitate improved efficiencies. Ensure active and ongoing communication of operational issues between clinical operations, product development, biostatistics and data management and other support groups as required for your role and identify critical project/study tasks/issues, and recommend appropriate remediation activities. Share vendor experiences with peers to provide transparency on all vendor-related issues to capture within vendor governance. Highlight and provide alternative solutions for conflicting priorities within therapy areas working all stakeholders (internal and with the vendor). Promote vendor strategy by setting expectations and establishing performance measures with vendors throughout life-cycle phase. Provide input into the identification of vendors during the selection process. (35%)
3. Engage in department-led initiatives. Contribute to the completion of organization projects and goals by (a) acting as a team member, (b) effectively linking team and functional areas, (c) constructively and (d) delivering outsourcing expertise and support. Oversee and develop contract analyst and provide direction as needed. Continuously improve professional skills by participating in internal and external developmental opportunities. (15%)
4. Sourcing Strategy – Participate in setting strategic direction of the organization. Look for opportunities to add value that create economic and productivity benefit. Develop and introduce ideas, practices, technologies or interpretations to Sepracor from industry standards and successfully champion – manage associated change. Implement and drive sourcing strategy as a core team member and challenge decisions as appropriate. Actively analyze and review vendor relationships, recommend adjustments/changes and opportunities to improve the Sourcing Strategy. (15%)
Minimum education requirements Bachelors
Experience required 5 - 7 Years
Knowledge & skills (general and technical) Education level and/or relevant experience(s):
• BS / BA or equivalent with five (5) or more years outsourcing experience
• Minimum five (5) years experience in Clinical Development or similar environment
Knowledge and skills (general and technical):
• Good decision and problem solving ability
• Strong computer skills along with working knowledge of various databases
• Working knowledge of various contract types and complexity levels
• Able to handle projects independently with minimal supervision
• Takes initiative in solving problems and demonstrates self-reliance and resourcefulness
• Has good time management, planning and scheduling skills
• Strong written and oral communication skills
• Demonstrates teamwork, establish relationship and build trust with internal and external stakeholders
Confidential Data All information (written, verbal, electronic, etc.) that an employee encounters while working at Sepracor is considered confidential.
Compliance Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sepracor are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Marlborough, MA
Marlborough, Massachusetts
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