Project Manager III - R&D Project/Program Management

Teva Pharmaceuticals; West Chester (Chester County); Presencial; USD 120 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health Insurance

401(k) with company match

Paid time off

Flexible working options

Resumo da oferta

Teva Pharmaceuticals is seeking a Manager, Centralized Monitoring to lead RBM strategy across assigned studies within Global Biometrics. You will develop and implement CMPs, and build dashboards using CSA and Spotfire to assess data quality and risk in real time.

You will partner with Medical Monitoring, Clinical Operations and Data Management to drive data-driven decisions, improve oversight, and ensure compliance with regulatory guidance.

Qualificações

• 5+ years of professional experience required.
• Bachelor's degree or higher or equivalent experience.
• Strong oral and written communication skills.
• Ability to manage multiple projects independently.
• Experience with RBM practices and strategies preferred.
• Knowledge of regulatory guidance (ICH E6 R2, Transcelerate) preferred.

Responsabilidades

• Lead and implement the risk assessment process on assigned studies and facilitate cross-functional input.
• Map study risks to data and procedures to define oversight responsibilities.
• Author and maintain CMP describing aggregate and real-time reviews.
• Perform regular reviews to identify trends and data anomalies.
• Develop and monitor quality and risk indicators to improve data quality.
• Design tools and dashboards (CSA and Spotfire) for review cycles.
• Collaborate with Medical Monitoring, Clinical Operations, and Data Management teams.
• Oversee issues management across the study life cycle.

Conhecimentos

Communication skills

Project management

Virtual collaboration

RBM knowledge

Regulatory knowledge

Formação académica

Bachelor's degree or higher

Ferramentas

Medidata CSA

Spotfire

Descrição da oferta de emprego

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

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.

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 [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.