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Clinical Specialist Manager, Clin GDN

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

Domain solution development, process development, process pilots and process transition of key business processes that will be transitioned and executed by the global process delivery center. Process improvement initiatives liaise with the Quintiles stakeholders and support teams to review and provide oversight. Implementation of specific process initiatives arising out of transformation/innovation/ process re-engineering programs Competency development in select process areas by identifying focus areas, develop training, identify people and mechanisms to scale up the competency Act as a clinical research subject matter expert for various initiatives Mentor projects/ initiatives on industry best practices Thought leadership on clinical research industry trends, impact of emerging regulations on operations Contribute to intellectual property generation by creating frameworks, collaterals, whitepapers and accelerators relevant to the areas of expertise. Collaborate with respective stakeholders, including operations teams, global teams, and other functional managers as appropriate Collaborating with peer business process specialists and promoting cross functional synergies. Handhold the delivery team and provide functional support to the teams on an ongoing basis Process Quality and audit initiatives - Identify impacted areas, provide root cause and implementation of corrective and preventive action. Participation in industry and academic events showcasing Quintiles capabilities and expertise. Develop templates, re-usable assets and best practices Develop and deploy competency assessments working with the Global training department Creation of business cases, proposals and presentations related to the relevant area of expertise Support RFIs/RFPs a for business generation Review and sign off on project requirements, process flows, gaps, and design documents. Perform the User Acceptance Testing; ensure the quality of the deliverable is in line with what has been agreed in the project requirements. Work with Enablement group to test the platform perform user testing Work with Quality management to develop the QM plan for the work stream. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES In depth knowledge of Clinical Research functions like Monitoring, Project Management and Regulatory. Awareness of multiple styles of workings of sponsors, vendors and other stake holders. Strong communication and interpersonal skills, including good command of English language Excellent problem solving skills Good teamwork skills Ability to work under limited direction Basic software and computer skills, including MS Office applications. Familiarity with related systems and softwares utilized in clinical operations. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Qualifications MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences or related field and min 7 years with relevant clinical research experience; or equivalent combination of education, training and experiencePHYSICAL REQUIREMENTS Extensive use of keyboard requiring repetitive motion of fingers. Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Regular sitting for extended periods of time
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 7-12


Clinical Research | Quality Assurance/ Control | Research Scientist
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