Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Program Lead- Clinical Data Sciences
Job Description
• Acts as the key scientific and technical data management expert at the asset level; define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as Risk Based Monitoring (RBM) standards, tools, data provisioning, and reporting
• (M04 career tract level only) Builds and oversees a high performing team of Clinical Data Scientists to deliver data monitoring and management expertise to Research/Business Units and other Global Product Development lines in a high quality and timely manner
• Serves as a functional driver of Quality Gates and manages Significant Quality Events (SQEs)
• Anticipates, oversees and influences change to position efficient, high-quality operational delivery
• Develops creative solutions to complex problems within and beyond scope of expertise (e.g. TA, discipline, department)
• Assumes accountability and as needed responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, and third party study data due diligence and deliverables
• Manages risk appropriately to enable innovative solutions
• Establishes strong partnerships with BU/RU, department leadership and other functions to advance asset or indication goals
• Ensure work carried out by or on behalf of DMM is in accordance with applicable SOP’s and working practices.
• Ensures DM work is inspection ready and acts as a key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups within Pfizer.
• Helps develop a strong talent base within group of Clinical Data Scientists, preparing for long-term development needs, via mentoring or matrix management
Candidate Profile
• Bachelor’s degree required. Degree in scientific field preferred. Master’s degree preferred.
• Knowledge of vendor processes and best practices in outsourcing. Must be capable of building strong relationships with Partners and other vendors.
• At least 15 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency.
• Supervisory experience required
• Oncology-related experience is highly desirable.
• Data Management and clinical trials expertise with a thorough understanding of the processes associated with clinical drug development and data analysis operations required for the reporting of clinical trials and global regulatory submissions.
• Thorough understanding of regulatory requirements and relevant data standards. CDISC knowledge and experience are preferable.
• Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills
• Sound knowledge and experience working across international boundaries and cultures.
Additional Information
Qualification : M.Pharm, M.Sc, B.Pharm, B.Sc
Experience : 15 years
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Data Sciences
End Date : 25th August, 2018
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