Job description
Job Description
Position Summary:
Reporting to the Sr. Director of Clinical Outsourcing this position will be responsible for assisting team members in the preparation, tracking and finalization of clinical site and vendor agreements as well as support of non-clinical agreements. This will involve building partnerships with the Clinical department's leadership, Procurement, Legal, FP&A, and non-clinical departments as appropriate to ensure that outsourcing and contracting vendor needs are met and handled in an optimal and efficient manner that is consistent with company policy, as well as legal, government, and regulatory requirements where relevant.
Job Responsibilities
Education
Travel Required: Minimal (up to 10%)
Position Summary:
Reporting to the Sr. Director of Clinical Outsourcing this position will be responsible for assisting team members in the preparation, tracking and finalization of clinical site and vendor agreements as well as support of non-clinical agreements. This will involve building partnerships with the Clinical department's leadership, Procurement, Legal, FP&A, and non-clinical departments as appropriate to ensure that outsourcing and contracting vendor needs are met and handled in an optimal and efficient manner that is consistent with company policy, as well as legal, government, and regulatory requirements where relevant.
Job Responsibilities
- Assist with preparation of clinical and non-clinical CDAs (Confidentiality Disclosure Agreements).
- Support the selection, and onboarding of clinical and non-clinical vendors
- Assist in the development, review and negotiation of clinical contracts
- Assist in management of non-clinical contracts and budgets, including assistance with resolving financial issues
- Support input of contract documents into ZIP and track progress of development to completion (e.g. PO development, approvals, expenditures)
- Assist with process improvement initiatives to enhance outsourcing efficiency and standardization
- Assist with the tracking of vendor budgets, negotiated savings, etc.
Education
- BA/BS in a Scientific, Business or Legal discipline, or related experience.
- 0-2+ years of Biotech, Pharmaceutical, and CRO Outsourcing experience or relevant experience.
- Excellent communication, written, and verbal skills.
- Ability to drive the collection, organization, and analysis of financial and operational data.
- Proficiency in contracting, financial, legal, and business acumen with global studies.
- Introductory proficiency with the following: contract development, financial/budget development and tracking and have finance, legal and business acumen.
- Basic knowledge of Clinical Trial Process.
- Ability to manage change successfully and identify process improvements.
- Excellent computer skills and aptitude for learning new systems.
- Ability to collect, organize, and analyze financial and operational data.
- Excellent written and verbal skills.
- Negotiation skills/ strategies.
- Basic budgetary understanding and capability; able to effectively manage expenses.
- Proactive, self-starter – take initiative beyond minimal expectations
- Ability to work under pressure and handle multiple, complex projects at a rapid pace
- Embrace core values
Travel Required: Minimal (up to 10%)