Contract and Budget Specialist
Your tasks and responsibilities
• Develop the project country level budget (includes all necessary
components: investigator grants, CROs, administration, etc.) in
accordance with the clinical study protocol, project requirements, and
through analysis of industry standards and historical data with
supervisor oversight, as needed. Ensure clinical procedure frequency
and cost data are consistent with the project objectives and the
protocol. Review and finalize the budget with the Country Lead Monitor
(CLM), and obtain approval through the appropriate financial hierarchy.
Generate budgets for investigator sites based on final approved study
• Central record project country level budget (includes total budget
with detail items calculation, budget phasing, and spending trend).
General observe budget with Country Lead Monitor (CLM) each rolling
forecast and record any justification. All record should be published
in GSM China internal platform, review and managed by CLM periodically.
• Supports legal to update country level investigator agreement
according to global SOP update, country specific regulations
requirement and/or local needs, coordinate contract templates review
among other functions. Final contract template should be uploaded to
BHC PH Law's website as SOP required; Draft clinical trial contract
related documents based on local needs, the documents including but not
limited to country specific contract template, notification. Coordinate
cross function review of such templates and get final review from
legal. Lead periodical review of such documents. All documents should
be approved by GSM and legal head.
• Drafts study specific investigator agreement with payment term
according to final project country budget, clinical trial protocol and
finance requirement. The final investigator agreement should be review
and approved by CLM. Provide training to study country team about the
• Support sitespecific investigator agreement negotiation. Provide
contract template training to CRA under legal's supervision, if needed.
Set up start-up plan with CLM, join CRA meeting during start-up period
to discuss start-up issues related to contract negotiation.
• Review and approve the contract within contract management policy,
coordinate with other functions such as legal, Finance until the
• Identifies process improvement opportunities related to contracting
and budgeting and suggest improvements, set up database, checklist to
optimize contract management process. Shares best practices with less
senior staff to continuously improve work processes and eliminate
• Ensure compliance with all relevant SOP's, GCP and ICH
The Contract and budget specialist must posse an in-depth knowledge of
clinical development e.g. ICH-GCP, monitoring, study management
processes, and applicable legal and regulatory requirements.
Additionally, strong leadership, motivational, and interpersonal skills
are critical. He/She must have a bachelor's degree (or equivalent) and
5-7 years of experience in the healthcare field, pharmaceutical
industry or clinical research/development. 2 years of experience in
clinical trial contract management.
Experience in review study budgets within the pharmaceutical or related