Clinical Contract Associate I

Job Description

Primary Job Function:

The Clinical Contracts Associate (India) will support the US & CALA Clinical Contracts, Budgets & HCP Agreements team, responsible for developing & amending site budgets, initiating and managing licensing agreements, HCP agreements, and budget development activities with supervision. Additionally, this role will be expected to contribute to broader functional initiatives to enhance efficiency and compliance across clinical contract operations.

Core Job Responsibilities:

• Manage site budget template for new studies (multi-country) & budget template updates for protocol amendments under close supervision of budget manager.
• Manage licensing agreements process for clinical trials tools/outcome questionnaires, including translations as requested by Project Management with oversight.
• Update budget comparison files for standard & invoiceable items based on site-specific approved budgets in a timely manner to support Site Operations and Project Management finance forecasting needs.
• Manage HCP agreement related tasks as assigned, including uploading documents within GPAS, FMV assessments, and routing agreements for signatures as requested by the HCP Team CCAs with oversight.
• Manage assigned routine amendments (such as PI change, site name change) in support of the US/CALA CCA team.
• Support functional initiatives as directed and assigned.

Position Accountability/Scope:

u00B7Support US & CALA Clinical Contracts & Budgets team for creating site budget templates for new studies (multi country) & updating budget templates for protocol amendments

u00B7Budget comparison file updates for standard & invoiceable items based on approved budgets for study specific budget trending (across sites) and forecasting need support for Site Operations and Project management.

u00B7Execute tasks for managing HCP Agreements including uploading documents with GPAS, FMV assessments, routing agreements for signatures under manager oversight.

u00B7Manage assigned routine amendments (such as PI change, site name change) in support of the US & CALA CCA team.

Minimum Education:

Bachelor's degree

Minimum Experience/Training Required:

u00B72u20133 years of experience in clinical research, preferably within the pharmaceutical, medical device, or CRO industry

u00B7Background in Finance/accounting and excellent Excel/Analytical skills

Experience in developing and negotiating clinical research contracts, engagements with HCPs, and budget development is highly preferred