Clinical Site Contracts Specialist
121 Oyster Point Blvd South San Francisco, CA 94080
Clinical Site Contracts Specialist
Responsible for the development and analysis of contractual relationships which includes but is not limited to drafting, negotiating, and finalizing contracts (clinical trial agreements/CTA) related to clinical trials. Assists in and/or directs the development of terms and conditions. Provides specialized support to trial managers and clinical group in the planning, execution and control of contracts.
Responsible for drafting, negotiating, and finalizing clinical trial agreements (CTA) with sites as they relate to various clinical projects.
Facilitate CDA & clinical trial agreement execution process and participates in site selection and startup activities globally.
Maintains positive and collaborative relationship with CRO partners. Assures coordination of outsourced contracting activities, and the main point of contact for escalation.
Reviews informed consent forms to assure that these documents are consistent.
Determine potential needs for contract amendments and manage amendment execution.
Assure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
Assume responsibility for all aspects of document and metrics tracking.
Adhere to SOPs, ethics and departmental compliance as determined by management as well as R&D companies, corporate, HCC and QA guidelines.
Contribute to improving processes and establish refinements that reduce cycle time and improve efficiency in the initiation of clinical trial sites.
Collaborate with other members of the Contracts team to ensure proper dissemination and management of knowledge and to meet team goals and objectives.
Comply with requests from QA and auditors.
Proactively leads process improvements or other projects that enhance and streamline contract processes, systems, tools and other resources
Reviews, analyzes and tracks in-process and on-going agreements
Prepares and disseminates information regarding contract status, compliance, modifications, etc.
Reports the status of contracts to internal clients using established processes
Trains others group members on group/departmental processes and operational activities and customer specific processes
Leads or supports internal audits of department processes and procedures
Strong contract language drafting and negotiation skills
Proficient with Word and have a working knowledge of Excel and Microsoft Access
Excellent written and verbal communication skills; professional manner
Able to work effectively and efficiently with all levels of management and personnel
Able to comprehend and manage business contracts and other complex documents
Able to handle multiple projects in a timely manner
Must have excellent attention to detail
Strong commitment to customer service
Demonstrated ability to maintain problem-solving approach in collaboration with internal and external contacts
Strong organizational skills; able to organize and follow through with projects; ability to efficiently handle large volume of contracts
Strong organizational and planning skills and meticulous attention to detail
Able to work independently while exercising initiative, flexibility and good judgment
Paralegal or JD with Contract Management experience in Biotech Preferred
4 or more years of experience in life sciences legal or contracts management field