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Bayer Study Manager in United States

Why Bayer

We pride ourselves in being research-driven, with businesses in CropScience and HealthCare. We are also proud of our environmental record, our safety performance, and our manufacturing expertise. You can only imagine our pride at being named one of Fortune magazine's most admired companies.

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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life.

At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Apply online

Study Manager

Your tasks and responsibilities

The primary responsibilities of this role, Study Manager, are to:

  • Manage and be responsible for all activities related to clinical pharmacology, complex phase I, extended phase I/II clinical trials from the approved study concept to the clinical study report;

  • Manage all Study Team activities as defined per SOP/OI and ensures the organization of regular Study Team meeting;

  • Manage the selection and oversight of External Suppliers (e.g. site management and monitoring Clinical Research Organization (CRO), Central Labs, central ECG reading center, etc;

  • Develop and manage budget, timeline and quality of the study and its deliverable. Responsible for forecasting and tracking of study costs, ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT);

  • Responsible for all start up activities e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight;

  • Occasionally writes protocols and amendments in collaboration with study team member;

  • Responsible for study specific feasibility and site selection to meet study enrollment and timeline;

  • Together with OPL and ECL/CPL, responsible for developing the total external study budget and accountable for providing monthly and yearly estimates, tracking study budget, initiating payments, providing monthly information to controlling, OPL, ECL/CPL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issue;

  • Track and compiles patient enrollment, data quality and cleaning progress and overall study progress and ensures study timelines are met;

  • Responsible for training and oversight of CROs to ensure compliance with timelines and budget;

  • Develop appropriate study related training for monitor and site personnel according to GCP and company standard.

Who you are

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

The qualified candidate is required to possess the following:

  • BS degree with 6 plus years of healthcare experience (within Pharmaceutical clinical operations experience) of which 2 years is in early development clinical operation;

  • The ideal candidate will have solid clinical operation experience as a study manager working in early development managing patient studies or be a research nurse with the following experience:-

1). Study coordinator experience on Phase I clinical trials in a hospital research setting (a General Clinical Research Center);

2). Experience as a Study Manager/Clinical Trial Leader for a pharmaceutical company;

3). Experience as a CRA on Phase I trials;

  • Require in depth knowledge of the clinical trial management process including monitoring and study management processes, regulatory requirement, drug safety requirement, data management and statistical processes and budget and financial tracking;

  • In addition, the incumbent require proven project/external vendor management skills, including effective planning and organization skills, attention to detail and excellent follow through;

  • The position also requires awareness and understanding of cultural differences as well as regional operational differences.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Country:United States

Location:NJ-Cedar Knolls, NJ-Fairfield, NJ-Montville, NJ-Morristown, NJ-Parsippany, Residence Based, NJ-Wayne, NJ-Whippany, NJ-Paterson, NJ-Trenton, NJ-Cherry Hill, NJ-Egg Harbor Twp, NJ-Jersey City, NJ-Lakewood, NJ-Old Bridge

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