KEY RESPONSIBILITIES SHALL INCLUDE:

• Identify, contact, share CDAs, RFPs, study synopsis & obtain trial related quotations from various CROs and other vendors
• Perform pre-qualification visits to CROs/vendors & generate reports
• Coordinate with global CROs for the conduct of Bioequivalence and Phase trials
• Develop scope of work and define RACI responsibility matrix for the CROs
• Develop/review Master Services Agreement/Contract for the CROs
• Overview / communicate and escalate all CRO related issues with Bioplus management
• Develop/review various Clinical Study Protocols, Plans, SOPs and other Study related documents
• Initiate governance and kick-off meetings, as required
• Coordinate with State and Central Government bodies for necessary approvals
• Coordinate with other departments like Marketing, F & D, QA, QC, RA and Manufacturing teams for timely delivery/completion of a project
• Coordinate for initiation and collation of Regulatory documents and compile the Dossier for Regulatory submission, as required
• Maintain all clinical-related study files at Bioplus
• Any due diligence activities, as assigned by the management

EXPERIENCE

• 8 to 10 years sound experience in reputed Organizations

QUALIFICATION

• PhD or MD with Pharmacology background

KEY COMPETENCIES

• Ability to work both independently and within a team structure
• Proven ability to lead, influence and motivate colleagues and external partners
• Strong planning, presentation and interpersonal skills
• Strong work Ethics, Self-motivated, Dedicated & Results orientated
• Excellent in written and spoken English
• Multi Tasker, strong in systems, process to handle multiple projects/sites
• Can do attitude is a must
• Evaluation of strategic option, costs, time and completion strategy
• Strong internal co-ordination skills
• Ability to handle extreme pressure situations
• Excellent aptitude in written and oral English
• Problem Solver, Self-motivated, Team Leader