1+ months

Senior Manager, Data Management

Frazer, PA 15084
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!

Job Description

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.  

 

 

 

Qualifications

Requires strong leadership, quick learner, working independently.  Experience both in vendors/CROs oversight and "hands on" core DM activities and appropriate experience in Ecoa.

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.

 

REQUIRES:

Managers require at least five years of data management experience in a pharmaceutical or clinical research setting.

Bachelors 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. 

Experience with computerized clinical data management systems.  Thorough understanding of the drug development process, clinical trial methodology, GCP regulations, and data management principles. 

Experience in data management, systems, technical  and outsourcing. Experience in directly managing/overseeing service providers is desired. 

CCDM is preferred. 

Knowledge of SAS and database programming, systems integration experience and understanding of CDASH and CDISC standards are preferred. 

Understanding of FDA and international regulations and GCP. 

 

Function
Research & Development
Sub Function
Biometrics
Reports To

Director, Data Managment, Clinical Trial Data Sciences

Tevas 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.

Categories

Posted: 2019-06-28 Expires: 2019-09-08

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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Senior Manager, Data Management

Teva Pharmaceuticals
Frazer, PA 15084

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