inVentiv Health Clinical, a leader in drug development services, has a global infrastructure, therapeutic expertise, and commitment to quality that is unmatched in the industry. For pharmaceutical, biotechnology, generic drug, and medical device companies of all sizes around the world, inVentiv Health Clinical can help you transform promising ideas into commercial reality.
Post: Senior Project Manager
Job Description
- Oversee interdisciplinary clinical research programs.
- Represent inVentiv Health to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
- Lead clinical team to ensure quality, timelines and budget management.
- Responsible for TMF Management Plan and quality and completeness of TMF for assigned projects.
- Accountable for the financial performance of each project assignment.
- Accountable for all project deliverables for each project assigned.
- Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
- Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
- Accountable for maintenance of study information on a variety of databases and systems.
- Responsible for study management components of inspection readiness for all aspects of the study conduct.
- Oversight for development and implementation of project plans.
- Plan, coordinate and present at internal and external meetings.
- Direct the activities of assigned Project Support staff
- Prepare project management reports for clients and management.
- Implement resource strategies to achieve project goals.
- Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
- Participate in bid defense meetings where presented as potential project manager/director.
- Lead operational input to proposal development and pricing including proposed operations strategy.
- May train and support new Project Managers.
- Set priorities and schedule activities of departmental resources, implement company objectives, and create alternative solutions to address business and operational challenges
- May provide line management oversight as required by client contract/project
Candidate Profile
- Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred
- Ideally Project Management qualified i.e. Prince II or PMP / equivalent
- Seven years relevant clinical research experience with an understanding of clinical drug development and clinical trials operations.
- Four years’ experience managing projects
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
- Strong organizational skills.
- Strong ability to manage time and work independently.
- Direct therapeutic area expertise.
- High proficiency with full MS Office Applications, including MS Project
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
- High level of competence in English language
- Ability to travel as necessary (approximately 25%)
Additional Information:
Qualification: Bachelor's Degree
Job ID: 13461
Location: Pune/ Hyderabad
Industry Type: Clinical Research
Functional Area: Project Manager
Last Date: 25th September, 2016
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