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Bayer Senior Study Manager in Parsippany, New Jersey

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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

Senior Study Manager

Your tasks and responsibilities

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

  • The Sr. Study Manager is the main interface to all cross-functionalstudy team members (data management, statistics, bioanalytics, clinical supplies, insurance group, clinical trial registry etc.);

  • Moreover, he/she need to closely interact with the OPL as well as the ECL/CPL to ensure that study achievement are in line with the overall strategy and timeline for the project;

  • The Sr. Study Manager has to ensure the adequate management of all governance committee involved in the study conduct, i.e. PRC, submission/approval by competent HA and IRBs;

  • For the assigned studies, the Sr. Study Manager is the main contact partner for all external service provider involved in the study conduct and need to ensure adequate oversight;

  • Develop and Lead a Study team, manage all Study Team activities as defined per SOP/OI and ensure the organization of regular Study Team meeting;

  • Develop and manage budget, timeline and quality of the study and its deliverable;

  • Responsible for forecasting and tracking of study cost ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT);

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

  • Together with OPL and ECL/CPL responsible for selection andoversight of External Suppliers (e.g. site management and monitoring, CRO, Central Labs, central ECG reading center, etc.);

  • Develop the total external study budget and accountable for providing monthly and yearly estimate, 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 issues;

  • Write protocols and amendment in collaboration with study team members;

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

  • Responsible for timely delivery of 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;

  • Track and compile patient enrollment, data cleaning progress and overall study progress and ensures study timeline are met;

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

  • Ensure accurate data collection, protocol adherence, patient safety, PK, PD, biopsy sample integrity and GCP compliance;

  • Escalate severe deviation to a key parameter (i.e.recruitment, timeline, patient safety, protocol compliance, data collection/cleaning, budget) after discussing and in alignment with the Study Team to OPL and /or ECL/CPL and functional manager;

  • Point of contact for managing/answering question related to trial procedure and patients’ eligibility;

  • Ensure clinical trial registry and result posting according to global requirement and guideline, manage the study insurance according to required timeline;

  • Ensure set-up, maintenance and Quality Control of the study Trial Master File (TMF);

  • Conduct lesson learned at any point in time when requested bymanagement or any Study Team member and mandatory at study closure;

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:

  • Bachelor’s degree with 8+ years of healthcare experience of which 5 years working in clinical operation (early phase) pharmaceutical including direct monitoring and clinical trial/study management experience;

  • Ideal candidate will have solid clinical operations experience working as a study manager including 2 years of monitoring experience and a minimum of 3 years of study management experience;

  • Clinical Practices (GCP), federal regulations and internationalregulations (International Harmonization Committee-ICH regulations);

  • The position also require strong awareness and understanding ofcultural differences as well as regional operational difference;

  • Demonstrated leadership in project management and vendor management;

  • Effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, and excellent

  • Interpersonal, decision-making and issue resolution skills are required;

  • In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through.

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

Functional Area:

Entry Level: