Manager, Development Business Operations, Site Contracts I/II
Duration: 12+ month
Location: Foster City, CA 94404
Summary:
Position will be accountable for the drafting, negotiation, and review of global Phase I through IV clinical investigative site and related ancillary contracts (together referred to as “site contracts”) including both language and budget, the management of Functional Service Providers (FSPs) involved in the contracting process. Will require oversight of contract activities for multiple clinical development programs within the various therapeutic areas, ensuring Contract Managers and FSP provide adequate level of staff to complete contracts in an accurate, consistent, and timely manner. Must coordinate with the FSPs, Clinical Operations and Legal departments to manage and complete the site contract process throughout study duration. Responds and resolves complex issues associated with domestic and international contracts with support from more senior staff and Legal department. Ideal candidate will have demonstrated success in working collaboratively with stakeholders, especially senior Development Business Operations management.
- This role can manage the day-today activities in complex clinical trials contracts (CTA) and budget negotiation processes.
- Focuses on site clinical trials contracting, fair market value (FMV) compliance of site contracts, and accountability as it relates to FSP management and site start-up.
- Works with Functional Service Provider (FSP) to implement Site Contracts CALM Contracts Process to ensure efficient delivery of fully executed contracts.
- Manages the day-to-day activities of multiple areas in moderately complex clinical contracts and finance. Including but not limited working closely with internal clinical operations as it related to rapid study sites.
- Evaluates contract and budget changes requested within CTA and identifies business and/or legal risks manage the issue to resolution by proposing and providing alternative solutions to legal or senior management.
- Identifies issues/problems and provides recommendations for solutions.
- Demonstrates ability to make critical decisions related to projects and tasks.
- Demonstrates ability to work in fast paced and changing environment
- Assists other staff in resolving moderately complex issues relating to contract negotiation and management.
- Ability to develop use spreadsheets and tracking tools.
- Manages relationships in conjunction with the Clinical Operations as it relates to clinical trials contracts
- With the support of internal customers and the legal department, within the contract negotiation process.
- Leads the contract life cycle management process for assigned Clinical Trial Study.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- This role demonstrates an in-depth knowledge of negotiations of clinical trials agreements.
- Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development.
- Demonstrates an understanding of the regulatory implications of contracts as related to clinical research.
- This role must be able to interact on high level with the clinical teams, and project management to provide oversight of negotiations of CTA and clinical budgets.
- Completes tasks and projects under minimal to no supervision.
Required Years of Experience:
7+ years of experience with a BA in a relevant discipline.
5+ years of experience with a MS/MBA in a relevant discipline.
Top 3 Required Skill Sets:
- Contract negotiation experience
- Experience with clinical trial budgets/compliance
- project management skills.
Top 3 Nice to Have Skill Sets:
- Advanced knowledge of oncology clinical trials, experience negotiating and creating detailed clinical trial budgets.
- Understanding and skill in developing metrics and metric visualizations around contract turn around time data.
Other skills:
- Competent in computer skills (Microsoft Office including Excel, Word and PowerPoint).
- Relevant experience typically includes contract language and budget negotiation, and application of project management principles.
- Global Site Contracting experience a plus.
- Skilled at project management, able to meet deadlines on multiple concurrent projects and work collaboratively with and through others.
- Demonstrates patience and is able to break down complex information into digestible pieces.
- Able to work in a rapidly changing environment with a high tolerance for ambiguity.
- Aptitude to thrive in a fast-paced, changing environment while producing quality work under time constraint.
- Ability to analyze situations from organizational, departmental perspective (ie considers strategy, culture, structure, systems, people, processes and planning).
- Ability to work effectively in a team environment and creatively solve problems.
- Must exhibit a positive attitude, a respect for others, a results-oriented approach and ability to work independently as well as collectively.
Company Description:
LS Solutions is a privately owned minority certified niche consulting and managed solutions firm head quartered in Princeton, NJ servicing Life Sciences industry with international office locations in India, Singapore, Germany, Belgium and United Kingdom.