Teva Pharmaceuticals
Website:
tevapharm.com
Job details:
We Are Teva
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
The Opportunity
Ensures data management activities and deliverables for area(s) of responsibility are completed in line with business requirements and company objectives.Performs Central Monitoring activities.Evaluates and approves service level agreements.
Oversees service providers to perform core data management functions including CRF, edit check development, eCOA, user acceptance testing, data cleaning, reviewing listings, and database locking procedures.
Evaluates and makes recommendations related to inter- and intra-departmental processes in order to identify and implement efficiencies and quality improvement measures.
How You’ll Spend Your Day
- Leads and manages Data Management tasks outsourced to external vendors and ensures that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory requirements.
- Executes according to the Data Management outsourcing and related strategies and processes, developing positive partnerships with CROs and ensuring a high standard of deliverables is maintained.
- Executes according to the Central Monitoring plan, reviewing Central Monitoring systems for issues, leading/participating in the Central Monitoring risk review meeting
- Serves as the Data Management and Centralized Monitoring focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes.
- Supports collaboration, communication, coordination and prioritization within the department working in conjunction with Clinical Programming Lead.
- Participates and contributes to local and global departmental activities, projects and tasks, in close collaboration with Strategic Planning
- .Represents Data Management and facilitates project related integration with other groups, notably Clinical Research, Clinical Programming, Statistics, CQA and Regulatory
- Collaborate with other Clinical Trial Data Management leads upon need (e.g. Coding).
- Prepares and maintains timelines and resource plans for the assigned studies, and communicates to management any timeline or resource issues so that appropriate actions can be taken.
- Attends investigators’ meetings; gives input into the presentations that involve relevant data management topics; oversees presentations delivered by service providers or gives presentations. Ensures appropriate training for study team.
- Approves Data Management Plans for completeness and accuracy of required documentation according to SOP
- Provides input into CDMS requirements, assuring protocol requirements are met. Oversees and performs UAT on CDMS components as needed.
- Acquires knowledge related to drug development, clinical trials methodology, and applies the relevant information in recommending changes in data management to better satisfy business requirements.
- Follows Teva Safety, Health, and Environmental policies and procedures.
- Conducts other projects and tasks as assigned.
Your Qualification And Experience
- Bachelor’s Degree or higher, or equivalent amount of combined educational and work
- experience is required. Exceptional candidates may be considered with less years depending on experience and education.
- Senior Managers require at least 12+ years of data management experience in a pharmaceutical or clinical research setting.
- Experience in data management, systems, technical and outsourcing. Experience in directly managing/overseeing service providers is desired.
- Experience with computerized clinical data management systems.
- Strong understanding and experience with eCOA and ePRO systems and leading studies with eCOA.
- Knowledge of SAS and database programming, systems integration experience and
- understanding of CDASH and CDISC standards are preferred.
How We’ll Take Care Of You
At Teva India, care is at the heart of how we work. From your first day, you’ll be welcomed into a people-first culture built on inclusion, respect, and belonging.
That support extends to you and your loved ones through benefits designed for real life. These include comprehensive medical insurance, OPD coverage, annual health checkups, term life and accident insurance, and confidential emotional wellbeing support through our Optum Employee Assistance Program. You’ll also enjoy healthy meals at work, holistic wellbeing initiatives, and volunteering programs that help you give back to the community.
Your growth matters too. You’ll have opportunities to build future-ready skills, collaborate on projects with global teams, explore internal career opportunities, and learn through programs such as our AI-enabled Teva Twist program, R&D Academy, continuing education, and mentorship.
Join our vibrant workplace, where we celebrate milestones, festivals, achievements, and community impact together.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
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