About this role
## 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
The Manager, Centralized Monitoring is responsible for leading the implementation and conduct of a cross-functional risk based monitoring (RBM) strategy on assigned studies as part of the Data Sciences organization within Global Biometrics. The position is also responsible for developing the tools necessary to conduct both aggregate level and real-time reviews (i.e. Medidata CSA and Spotfire) according to the Central Monitoring Plan. Additionally, the Manager, Centralized Monitoring works closely with other groups to gather requirements and develop functional oversight dashboards and visualizations. This position is also responsible for providing professional expertise and leadership through leading and/or participating on non-project initiatives aimed at improving the effectiveness of the organization.
## How You’ll Spend Your Day
- Lead and implement the risk assessment process on assigned studies and facilitate cross functional stakeholder input.
- Map study risks to critical data and procedures in order to define the cross functional data oversight responsibilities ensure data consistency and alignment to the defined risks.
- Author and maintain the study specific Central Monitoring Plan (CMP) describing both aggregate and real-time patient level clinical and operational data reviews.
- Perform regular clinical and operational data reviews as described in CMP to identify, evaluate and report on emerging trends, meaningful data anomalies and detect potential fraud.
- Develop and proactively monitor key quality and risk indicators to enhance study data quality, support data driven decision making and risk mitigation strategies. Work with cross functional team to define appropriate thresholds and intervention strategies.
- Support development of a global KQI/KRI library and performance metrics to identify studies that may require further escalation.
- Design and implement appropriate tools, systems and processes to facilitate the conduct of review cycles, ensuring data integrity and quality (e.g. CSA and Spotfire).
- Liaise with Medical Monitoring, Clinical Operations, and Data Managementteams (and any other relevant functions) to develop study specific technology dashboard to facilitate any required cross functional review.
- Oversee the study issues management process to facilitate single source, full life cycle, issues management.
- Contribute and/or lead departmental process or innovation initiatives as assigned.
- Develop positive partnerships with service providers, manage and influence the strategic relationships and ensure a high standard of deliverables are maintained.
- Support collaboration, communication, coordination and prioritization within the department, across the organization and with services partners.
- Follow Teva Safety, Health, and Environmental policies and procedures.
- Performs other duties as requested.
## Your Skills and Experience
5+years of professional experience. 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.
- Strong and effective oral and written communication skills and interpersonal skills.
- Ability to manage multiple projects independently.
- Ability to work in a virtual, global and multi-cultural environment.
- Knowledge of at least one visualization tool (i.e. Spotfire).
- Experience with computerized clincal data mangement systems.
- Prior experience with RBM practices and strategies preferred.
- Knowledge of regulatory and industry guidances preferred (e.g. ICH E6 R2, Transcelerate).
- Professional accuracy, integrity, dedication and motivation.
## How We’ll Take Care of You
At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.
We offer a competitive benefits package, including:
• 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.
## Already Working @Teva?
Make sure to apply through our internal career site on Twist—your one-stop shop for career development
## 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.
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 [email protected] 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.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.