Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

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
 budget.
 • 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
 contract template.
 • 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
 contract approved.
 • 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
 redundancies.
 
 • Ensure compliance with all relevant SOP's, GCP and ICH

 

Requirements


 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
 i

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Country: China
Location: BeiJing

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Last update: Sep 4, 2018   Copyright © Bayer AG
URL: https://career.bayer.cn/opencms/opencms/job/FAP-National-Technical-Manager--SF20363.html