Senior Manager, Data Management

Teva Pharmaceuticals; West Chester (Chester County); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health Insurance

401(k) Match

Paid Time Off

Job summary

Teva Pharmaceuticals is seeking a Data Management Leader to drive data management activities for clinical studies, oversee outsourcing to CROs, and ensure timely, compliant deliverables. The role requires strong DM, eCOA, and CDISC knowledge with a focus on GCP and regulatory standards.

We value collaboration in a virtual, global team environment and offer comprehensive health benefits and retirement plans.

Qualifications

• Bachelor's degree or higher; extensive data management experience preferred.
• 5+ years data management in pharma/clinical research for managers/senior managers.
• Experience managing outsourcing to CROs and oversight of vendors.

Responsibilities

• Lead data management tasks outsourced to external vendors and ensure milestones stay on budget.
• Coordinate with CROs and ensure high-quality deliverables.
• Act as DM/Central Monitoring focal point for assigned studies and ensure regulatory compliance.

Skills

Data Management

eCOA/ePRO

Vender/Outsourcing Mgmt

Monitoring/QA

Education

Bachelor's Degree

Tools

CDMS

SAS

CDISC

Job description

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.

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.

Our Team, Your Impact

• 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, leding/participating in the Central Monitoring risk review meetings.
• 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 Skills And Experience

Education Required: 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.

Experience Required: Managers / Senior Managers require at least five years / seven 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.

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

Specialized or Technical Knowledge Licenses, Certifications needed: NA

Functional Knowledge: See “Experience Required”

Company/Industry Related Knowledge: Understanding of FDA and international regulations.

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

Job-Specific Competencies

• Strong and effective oral and written communication skills and interpersonal skills.
• Ability to work in a virtual, global and multi-cultural environment.

Salary Range

How We’ll Take Care Of You

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. 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. Request a reasonable accommodation by sending an email to [e-mail] with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.