Founded in 1849, 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 : Head of India Data Monitoring and Management
Position Purpose
The Head of India Data Monitoring and Management will manage all DMM activities and resources in India. DMM is a critical partner in the advancement of Pfizer’s development pipeline, and the Head of India DMM leads an organization with a significant and broad impact on Pfizer’s portfolio and overall position in the market. The Head of India DMM is also a key member of the DMM leadership team, and will play an instrumental role in creating and developing a brand new group that will become a major presence for DMM. The role requires experience in establishing and building a large research-focused organization, the development of strong working relationships with the other departmental functions to facilitate open lines of communication regarding project priorities, and strong technical experience with a comprehensive and expert understanding of Data Management, and a perspective on the field’s future evolution. The Head will innovate and drive the global DMM future strategy aimed to position Pfizer DMM as best in class in the industry, to ensure the critical advancement of clinical drug candidates.
Job Description
- Act as leader of India DMM across multiple programs and teams
- Build a brand-new DMM departmental presence that has a strong local culture while being a fully integrated member of the worldwide DMM organization
- Drive achievement of trial deliverables and submissions for DMM
- Ensure strong partnerships within global DMM and Pfizer colleagues and with external vendors
- Implement global clinical data monitoring and management practices and quality guidelines in compliance with regulatory requirements and Pfizer quality standards
- Set current and future strategy as a core member of the DMM Leadership Team
- Lead clinical and non-clinical special projects aimed to evolve DMM in line with the Pfizer organization and the changing landscape
- Build and maintain strong and meaningful linkages with the regional/national Data Management community
- Partner with Global Head to define organizational metrics and relevant Key Performance Indicators (KPIs) to drive a high performance organization
- Drive, monitor and report on implementation of worldwide DMM initiatives and routine DMM deliverables
- Ensure that all staff fully understand the requirements of the job and are clear regarding the DMM deliverables across the Pfizer portfolio.
- Ensure development and implementation of site-specific change management based on worldwide strategies and standards; and in collaboration with other local functional heads.
- Administer and manage the DMM group in terms of local HR issues, goals development, performance management, application of Pfizer policies / procedures and recruitment.
- Ensure staff are qualified to perform their duties and complete training as required by the DMM curriculum
- As requested, deputize for the responsibilities of the Global Head of DMM
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Candidate Profile
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Experience / Professional requirement
- Ideally 15 or more years’ experience in drug development with at least 8 years in Clinical Data Management
- At least 10 years' line management or global project team leadership experience
- Clinical development and business experience in order to have a thorough understanding of regulatory processes at a global level
- Recognition in peer community as expert in topic area
- Ability to leverage network to establish/maintain contact with scientific community
- Exceptional technical and problem solving skills, and ability to evaluate computer systems for Data Management.
- Excellent understanding of clinical trials methodology, GCP and medical terminology
- Experience of interaction with major regulatory authorities (not only in India)
- Ability to work under pressure, demonstrating a high level of initiative and flexibility
- Demonstrate effective and innovative leadership, with substantive experience building and leading a team
- Excellent organizational, planning, resource and global project management skills
- Advanced interpersonal and communication skills and ability to manage effectively in an international organization
- Executive capability to mentor and coach associates
- Superior people management skills with demonstrated positive leadership, innovative and collaborative behaviors
- Ability to work effectively in a multi-cultural context and knowledge of team development principles
- Ability to provide leadership and management oversight, with particular emphasis on the ability to lead process development and improvement initiatives
- Proven ability to manage the performance of others to meet business objectives as well as colleague development objectives
Technical Skill Requirements
- Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)
- Project management skills that can be used to facilitate efficient resource allocation and ensure adherence to timelines
- Excellent verbal and written communication skills in relating to stakeholders and colleagues
- Demonstrated ability to create clear written professional communications
- Excellent knowledge of drug development and knowledge of methodology of clinical study and drug development
- Knowledge/experiences of quality control
- Knowledge of ICH guidelines and regulatory requirements
Additional Information:
Experience: 10 Years
Location: Chennai Device - Hospira
Education: Degree in life science, pharmacy
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Management
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