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Title: Senior Clinical Contracts Manager
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Contract – 6 months
- Pay rate: $75-79/hr.
- Job Location: San Francisco, CA
- Job# bh12547
Sr. Clinical Contracts Manager
Manages the negotiation, structuring, and management of contractual documents that establish business relationships with clinical trial sites. Defines the scope of clinical trial services through facilitation of cross-functional review and ensuring contracts align with clinical trial protocols and internal expectations. Advises management of contractual rights and obligations and provides interpretation of terms and conditions. Reviews and approves documents for protection of the company's contractual posture and adherence to company policy. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
- Works on issues of diverse to complex scope where analysis of situation or data requires evaluation of a variety of factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements policies when selecting methods, techniques, and evaluation criteria for obtaining results. Assures adherence to budgets, schedule, work plans, and performance requirements.
- Oversees and manages all aspects of a contracting for the conduct of clinical trials in accordance with our SOPs, ICH/GCP regulations and study-specific manuals and procedures.
- Develops and administers schedules, performance requirements and metrics that will have the greatest impact on improving the contracting processes.
- Serves as a liaison with internal stakeholders and/or other external customers regarding contracts related issues.
- Monitor’s partner and clinical trial site relationships to meet contracting expectations of services and requests.
- Analyzes and understands the scope of work, budget estimate and terms and conditions of contracts to assess alignment with clinical study assumptions and scope; makes recommendations to senior management on contract structure.
- Ensures adherence to established contracting policies and procedures by providing compliance information to various departments.
- Notifies management of compliance deficiencies and relationship issues.
- Compiles contractual information for budget and financial purposes, complex cost reimbursements and billing.
- Interfaces with a variety of senior internal and external customers providing guidance and information on complex contractual matters to meet requirements for contracts. Identifies and disseminates information to critical personnel with regard to changes and updates relating to contracts.
- Works with appropriate management team members to ensure monetary information for contracts is adequate.
- Other duties as assigned.
• A minimum of a Bachelor’s degree in Business Administration or related discipline is required. Equivalent experience may be accepted.
• An ABA-approved paralegal certificate or other comparable legal experience is highly desired. Professional certification or advanced degree is a plus.
• A minimum of 10 years of directly related clinical trial experience is required.
• Must be able to demonstrate a knowledge of contract requirements, analysis of contract performance, and special provisions.
• Previous experience working in the pharmaceutical, biotechnology or medical device industry is preferred.
• Previous experience with external relationship management is required.
• Requires knowledge of business and industrial practices including cost factors.
• Must be able to analyze and understand contract terms and conditions.
• Must be able to work with a high attention to detail.
• Must have excellent oral and written communications skills.
• Strong computer skills, including knowledge of databases and spreadsheets, are required.
- CLINICAL TRIAL
- CLINICAL TRIALS
- MEDICAL DEVICE
- PARALEGAL CERTIFICATE
- RELATIONSHIP MANAGEMENT
- CLINICAL STUDY
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