Title: Senior Contracts Manager
Duration: 12 Months (possible extension)
Location: Cambridge, MA
Clinical trial Contracts experience needed
Global experience a plus
Bachelors required (baseline) anything above that OK
Pharma/Biotech Experience needed
Clinical trial site budgets
Overseeing CRO’s is KEY
The specific key areas we are looking for are:
1) Clinical trial site budgets and contracts negotiation experience (at least a few years or direct experience in this particular space)
2) Excellent written, verbal communication skills and
3) Ability to collaborate cross functionally.
• Conducts contract management, administration, and execution for Clinical Development Operations group within R&D Organization
• Global site budget responsibility for development, management, and finalization
• Types of agreements include Service Agreements, Clinical Trial Agreements, Confidentiality Agreements, Investigator Initiated Study Agreements, Consulting Agreements and others as needed.
• Works independently and strategically to resolve complex contract issues.
• Manages study contracting on a program level, and has frequent interaction with, and oversight of, outsourced contracting vendor.
• Works with outsourced contracting vendor at functional level to develop standards and processes.
• Works withcontract requestor to determine appropriate contractrequired
• Responsible for global site budget development and management; assures fair market valuation of procedures and fees
• Develops a significant portion of agreements without the use of a template. Executes templates for increasingly complex business/legal terms with minor supervision.
• Manages outsourced contracting function; ensures compliance with established processes
• Oversees international agreements handled by Legal department to ensure compliance with established processes and metrics
• Independently negotiates agreements to completion
• Collaborates with Legal globally to ensure compliance with current legislation/guidance
• Subject to review and approval of Legal, exercises judgement related to legal/business issues that are outside normal template situation and are not routinely dealt with
• Ensures compliance with internal timelines, metrics, and processes
• Partner with global operational teams to ensure contract negotiations do not hamper study start up timelines, and support strategic objectives
• Proactively identifies areas for process improvement. Plays key role in independently leading process changes.
• Educates client groups on processes and more complex substantive issues (e.g. intellectual property provisions in contracts).
• Independently works with Legal department to research issues and formulate recommendations on individual agreements/discrete issues
• Demonstrates understanding of complex contract principles.
• Independently plans and organizes work involving several processes, projects or functions with reliable results. Exercises sound judgement in resolving non-routine problems.
• Effectively represents functional perspective to others.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• BA/BS or equivalent experience (10+ years direct industry contracting)
• Excellent interpersonal, influencing and negotiation skills
• Proven problem solving and decision making skills
• Experience with industry budgeting tool (GrantPlan or Grant Manager)
• Strong analytical skills and detail orientation
• Solid understanding of the clinical operationscontracting processes
• Excellent written and verbal communication skills