Contract - Clinical Outsourcing Associate
CONTRACT – CLINICAL OUTSOURCING ASSOCIATE
The Clinical Outsourcing Associate is a contract position within GBT’s Clinical Operations organization, reporting to the Director, Clinical Outsourcing. The Associate is accountable for the coordination of key activities such as vendor selection, contract management and the overall conduct of Clinical Outsourcing activities across the Development organization.
This position will be a self-motivated individual who is detail orientated, adept at multi-tasking and is a team player.
Essential Duties and Responsibilities:
- Contract, budget and procurement process management in support of GBT’s Development organization. This includes:
- Contract & budget document coordination
- Submission of contract requests via GBT’s procurement operations system (Zycus).
- Managing traffic of in-process contractual documents to ensure timely and compliant execution.
- Signature coordination, where applicable
- Through close collaboration with business process partners such as Legal, Finance and Quality Assurance; develop and maintain positive working relationships, transparent communications and process alignment.
- Assist members of the Clinical Outsourcing team in tracking departmental activities and properly filing documents, contracts, etc.
- Support Development staff in tracking, completion and filing of contract Change Notification Forms (CNFs).
- Coordinate the completion of Quality Assurance required documentation such as vendor selection forms, vendor qualification forms, etc.
- Ensure contractual, budgetary and procurement related information is regularly disseminated to appropriate parties.
- Contribute to continued process improvement efforts, including but not limited to department processes to ensure adherence to GBT’s standards and efficient operations.
- Gather and report data to support departmental KPIs and metrics intended to measure departmental processes and output.
- Adhere to GBT's working practices and Standard Operating Procedures (SOPs).
- Drive ad-hoc business projects as necessary.
- Bachelor’s degree (preferred) or equivalent experience.
- At least 2 years of professional experience, preferably in biotechnology or life sciences companies with a working knowledge of drug development and the conduct of clinical trials.
- Experience using Zycus (iSupplier, iContract) is a plus.
- Ability to work effectively in a team environment, but also to think independently.
- Excellent organizational skills and attention to detail.
- Strong analytical and business communication skills.
- Ability to efficiently perform multiple tasks and manage changing priorities in a fast-paced environment.
Fit with GBT culture:
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with GBT's Core Values
- Excitement about the vision and mission of GBT
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.