1. Generate country budget using local budget database and global budget from Grant Manager in the feasibility phase and deliver it to CTPS specialist to enter country budget into CTPS. Finalize country budget after country confirmation. Generate site budgets based on final approved country budget in preparation for CTAs. Maintain local budget in order to provide accurate data for development of the site level budgets to allow Country Lead Monitors/CRAs to know the latest average costs on procedures for their new studies. Take the ‘CTPS Key user’ role and communicate closely with CTPS specialist.
2. Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets. Ensure CTAs are executed in a timely manner in order to meet expected timelines for study start-up. Liaise with the legal departments of both Bayer and contract parties to ensure any content changes to the CTAs are mutually agreeable, and in accordance with Bayer's legally approved standard agreement language. Participate in Study kick-off meetings to obtain necessary information required for effective CTA execution.
3. Solid understanding of standard contract language to enable decision making pertaining to sections of CTAs when language modifications are proposed by external contract parties. If language is not compliant, discuss issues with legal and work with the legal department, sites, contractors or vendors to resolve them.
4. Manage CTAs ensuring all changes to agreements and corresponding components are updated according to Bayer legal standards and Bayer Global SOPs. Responsible to ensure annual review of all templates with the Legal department and Local Head of Monitoring and Site Management
5. Track the CTAs including coordination of timely updates with respect to CTA. Ensure accuracy of information and reconcile discrepancies between documents and the database. Responsible for posting of fully executed contracts in eFiliA and locally on the Clinical Operations secure drive.
6. Process for each study, internal approval forms and other documents which are required to ensure compliance with the Internal Signatory Process and are also required for annual audits.
7. Ensure excellent communication and collaboration as point person among clinical trial site personnel (Investigator, Study Coordinator, Institution's Legal Counsel) Bayer's Head, Clinical Operations, Legal Counsel and Manager, Insurance, throughout the contract negotiation process.
8. Responsible for preparing for internal audits by maintaining a complete and accurate paper trail for each site contract negotiation.
9. Negotiate Master Services Agreements (MSAs) with Institutions where Clinical Trials have been conducted and ensure they are reviewed prior to their renewal dates
10. Set up the value and tariff to import IMP for new assigned study and maintain IMP value for all studies with accuracy,
11. Execute payments to sites(e.g. investigator fee, cost for clinical related meeting) Collect invoice, register payments to system: e.g. SRM, Concur. Manage required data for disclosure reporting. Track info about payments to sites/supplied IMPs and enter data into relevant system(UlTra). Validate data before submission of disclosure reporting to government.
The incumbent is responsible for contract and budget of applicable Phase I and all Phase II-IV complex and global clinical trials. Key qualifications needed by candidate include the following:
1. Bachelor’s Degree (or equivalent) with 1-3 years of relevant healthcare experience including at least 1 year monitoring & site management experience
2. familiarity with the overall process for clinical trials and scientific principles of controlled clinical trials.
3. Knowledge of Good Clinical Practices(GCP), local and international regulations, and investigator grant parameters is desirable.
4. Effective written and verbal English communication skills, strong oral presentation, interpersonal, decision-making and issue resolution skills are required.
5. In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through.