Career in Clinical Development Services Agency as Director - Government Job | Emoluments upto Rs. 1,45,000/- pm

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pharma admission

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• Provide medical guidance and therapeutic area training for project team members and staff as required
• Develop training modules for therapeutic areas
• Develop project specific and protocol specific training
• Oversee development of training modules and project specific and protocol specific training in other therapeutic areas
• Be a faculty for training programs conducted by CDSA

Educational Qualifications
Essential: MD in pre-, para- or clinical subjects
Desirable: MPH, MSc or PhD in Clinical Trials, Epidemiology, or related fields

Work experience
Essential Experience: Post MBBS, Fifteen years’ experience of
• Medical monitoring and medical writing (includes time spent as functional Primary or functional/ technical Lead),
• Experience in safety reporting and management
• Experience in pharmacovigilance, medical coding and systems for adverse event review and reporting
• Clinical practice experience of at least two years

• Experience in working on trials / studies
• Experience with a CRO, pharmaceutical, biotechnology, or device company
• Experience of drug development and clinical trial administration background
• Demonstrated knowledge of drug development activities

• Leadership skills that include the ability to build effective medical and project teams, ability to motivate others, delegation, drive and timely/quality decision making
• Personal qualities that include the ability to gain trust and confidence with a variety of clients, good learning ability, managerial courage, action oriented and resilience in a fast-paced and rapidly changing environment
• Business/Operational skills that include customer focus, commitment to quality management and problem solving
• Influencing skills including negotiation and teamwork
• Effective communication skills that include the provision of timely and accurate information to stakeholders, proficient in English, strong written and oral communication skills
• Ability to develop and deliver presentations
• Ability to develop novel concept and techniques in medical monitoring
• Ability to develop and implement monitoring plans and SOPs
• Detail-oriented
• Ability to remain flexible as projects and priorities change
• Demonstrated ability to prioritize workload in order to meet multiple deadlines
• Ability to work independently with minimal guidance as well as collaboratively within a team setting
• Familiarity with basic computer applications: MS Word, Email, Excel, Internet
• Knowledge of all regulations and guidelines pertaining to the conduct of clinical trials on human subjects
• Ability to make evaluative judgments
• Ability to develop and revise standard operating procedures
• Knowledge of adverse medical event investigation, analysis, and reporting procedures and standards
• Ability to develop technical reports and manuscripts
• Ability to travel

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