Sepracor
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Marlborough,
MA
To provide Contract Management, Vendor Management and Financial Management support for current and planned clinical studies and related activities. Coordinate activities for assigned Strategic/Alliance partner, representing a TA area, under the supervision of Senior Director, Clinical Outsourcing. Manage multiple ad hoc projects and oversee programs simultaneously. Develop new concepts, techniques and standards and apply to create scientific and economic benefit.
Help set the strategic direction for all outsourcing opportunities within Clinical Operations, CRMA, Biostatistics and Data Management. The Associate Director will help align objectives including cost effectiveness, quality, and consistency of vendor management – helping to drive the implementation, execution and efficiency of the COG vision.
Essential Functions Act as Strategic / Alliance Partner main point of contact for TA area and/or functional area provider(s) – total relationship ownership. Responsibilities include (but not limited to):
a. MSA, Business Term Agreement and WO development and execution
b. Lifecycle contract management and vendor management, identification of critical issues and potential resolutions
c. Contractual and issue resolution
d. Ensure active communication internally and externally. Lead 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.
e. 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
f. Participate in study team meetings and other meetings to review the status of planned, ongoing and fully executed trials. Review and analyze activities across the Strategic / Alliance partner and look for areas of conflict within or between studies/programs/departments and teams.
g. Identify more strategic use and facilitate improved efficiencies
h. Facilitate remediation activities, 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.
i. Provide input into the identification of vendors during the selection process.
j. Develop and validate KPIs to ensure quality, cost effectiveness and consistency.
k. Ensure alignment with broader corporate goals and objectives inter-department and across other centers of excellence seeking to leverage higher-level relationships (50%)
Assist in ad hoc day-to-day outsourcing activities for transactional vendors including vendor selection, MSAs, CDAs, Consulting Agreements, Business Term Agreements and Vendor Management. (20%)
The Associate Director will have responsibilities, leveraging their industry experience, in mentoring, coaching and training all associates within the department. In addition, this position will have a strong focus in helping manage the day-to-day operations within the department (consistency, accuracy, process improvement, tracking and day-to-day operations). (20%)
The Associate Director will have responsibilities representing COG to the Supplier Community by liaising directly with these organizations. Interpreting current and emerging trends in the industry and creating scientific and economic benefits for Sepracor. Analyze value of existing relationships, review, replacing (as necessary) and conducing lessons learned. Act as a positive role model by demonstrating and living the core values. (10%)
Minimum education requirements Bachelors
Experience required 7 - 10 Years
Knowledge & skills (general and technical) Knowledge and skills (general and technical):
• Strong organizational, interpersonal and communication skills.
• Good leadership, decision and problem solving ability
• Strong computer skills along with working knowledge of various databases
• Strong knowledge of various contract types and complexity levels
• Ability to lead cross-functional matrix team to success with issues of moderate/high complexity
• Strong understanding of Clinical Operations
• Strong communication, negotiation, procurement and process management skills
• Relevant science or business background
• Takes initiative in solving problems and demonstrates self-reliance and resourcefulness
• Has good time management, planning and scheduling skills
• Demonstrates teamwork, establish relationship and build trust with internal and external stakeholders
Other requirements (licenses, certifications, specialized training, physical or mental abilities required) N/A
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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