Senior Analyst Clinical Contracts

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us

Summary:
The Senior Clinical Contracts Analyst will be an integral member of the Clinical Development Operations (CDO) department, assisting with the entire life cycle of contracts activities, developing, and negotiating clinical site budgets and conducting business operations as detailed below.

Principal Responsibilities:
Manage Clinical Contracts and Budgets for Global Trials:

- Serve as liaison for clinical contract requests such as CTAs, Service Agreements, and Ancillary Agreements and act as conduit between CDO and the Legal team
- Process all clinical contract requests and help facilitate early execution through the Contract Management System
- Perform consistent quality audits of work output and document knowledge base as needed
- Maintain accurate contract metrics on an ongoing basis
- Manage contract and budget escalations to the Seagen Legal team and study teams
- Serve as study lead accountable for the study contract status, escalations and reporting to the study team from study start to close-out.
- Collaborate with Seagen Study Start Up team to facilitate contract execution as required for site initiation visit and site activation.
- On-going interface with sites and vendors regarding contractual issues during the lifetime of the contract
- Establish and maintain direct site and vendor contact

For Sites Managed by Seagen:

- Manage the contract process through its lifecycle from initial template stage to fully negotiated contract
- Serve as liaison between the legal department and sites in contract negotiations
- Work closely with study teams to develop a budget template tailored for each study
- Negotiate and manage consistent site budgets that will assist in early site activation
- Respond to queries related to contracts and budgets
- Manage the contract escalation process to appropriate individuals, as needed
- Establish good customer relations with sites starting with the primary point of contact for budgets and contracts

For Sites Managed by a CRO:

- Review and approve the investigator fee template per country for each study before distribution to sites
- Serve as a conduit for request to Seagen Legal team for initial contract template
- Facilitate and manage weekly contract status update meeting with CRO
- Provide CRO oversight and track contract process for each study
- Serve as escalation point of contact for contracts and budget escalations from CRO
- Respond to CRO queries to ensure consistency with contract language and budget line items in accordance with Seagen standards

Other:

- Adhere to Clinical Operations or project specific quality documents (e.g., SOPs, work practices, training guides), as applicable.
- Participate in the development and testing of tools and procedures
- Workflow management

Qualifications:

- Minimum of four (4) years' experience working in contract management, proposal development or related field in the Pharmaceutical Industry, a biotech or CRO, finance and/or legal environment
- Minimum of four (4) years' experience negotiating contracts and budget and adjudicating contract fall back language
- Intermediate Excel and database management skills
- Knowledge of ICH/GCP in the provision of clinical trials
- Excellent negotiation skills
- Highly organized with excellent oral and written communication skills
- Work both independently and as part of a team

Education
- Bachelor’s degree in Life Science, Business, Legal or equivalent-
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