15 days old

Manager, Data Management

West Chester, PA 19380

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

 

Tevas Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.

Job Description

Teva is Growing! We are adding a Manager of Data Management to our team in West Chester, PA.  Relocation assistance may be available 

 

Essential Duties & Responsibilities Include:


         Ensures data management activities and deliverables for area(s) of responsibility are completed in line with business requirements and company objectives.
        Evaluates and approves service level agreements.
        Oversees service providers to perform core data management functions including CRF, edit check development, 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.
        Leads and manages DM 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 DM Outsourcing and related strategies and processes, developing positive partnerships with CROs and ensuring a high standard of deliverables is maintained.
        Serves as the DM 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 Data Management 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 Sciences leads upon need ( Centralized Monitoring and 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. 
        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.

Qualifications

 

Required:
        Bachelors Degree
        5+ years of data management experience in a pharmaceutical or clinical research setting. 
        2+ years experience in data analytics, data management, systems, technical and outsourcing. Experience in directly managing/overseeing service providers is desired.
        Understanding of FDA and international regulations and GCP. 
        Experience with computerized clinical data management systems.
        Thorough understanding of the drug development process, clinical trial methodology, GCP regulations, and data management principles.
         Strong understanding and experience with eCOA and ePRO systems and leading studies with eCOA
        Strong and effective oral and written communication skills and interpersonal skills.
        Ability to work in a virtual, global and multi-cultural environment.


Preferred:
        MBA Science
        CC

Function

Research & Development

Sub Function

Biometrics

Reports To

In process of validation

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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.

Categories

Posted: 2021-04-22 Expires: 2021-05-22

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Manager, Data Management

Teva Pharmaceuticals
West Chester, PA 19380

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