Our Client is an Indian biopharmaceutical company who is looking to onboard a clinical operations consultant who can help them with the following :-
1. Identification and selection of appropriate CROs through review of proposals and onsite selection visits and participate in CRO biding process.
2. Identification and selection of appropriate third party study vendors.
3. Drive the selection of CROs, vendors in the conduct of outsourced multinational clinical trials.
4. Develop budget and timelines as per the CDP from the inception stage of the project.
5. Manage program budgets and track overall quality on multiple clinical
6. Give strategic inputs to improve quality and efficiencies through
quality management plans.
7. Driving clinical trials independently across various geographies.
8. Oversee performance of CROs, third party vendors, including co- monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to CRO or seniors as appropriate.
9. Prepare robust CRO oversight plan and escalation path for conduct of the trial.
10. Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
11. Track and report on progress of study including site activation, patient enrollment, monitoring visits etc.
12. Monitor progress of trial and timelines as per the milestones and implement appropriate action plans in case of delays.
13. Negotiate and manage the budget and payments for investigative sites, as applicable.
14. Co-ordinate closely with the clinical development team and other cross-functional representatives, including Biostatistics, Pharmacovigilance, Regulatory/QA, formulation team, programe management etc. to ensure successful completion of all project deliverables within the required time frame and budget.
- Well versed with guidelines of various countries like USFDA, EMEA India, ICH-GCP, GLP, GMP etc.
- Good interpersonal skills
- Ability to build cross working relationships with other functions within company
- Excellent verbal and written communication skills
- Strong desire to take ownership of multiple projects
- Ability to adapt to changes in the work environment, method or approach