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Bayer Manager of Monitoring in Watertown, South Dakota

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.

Manager of Monitoring

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Manager of Monitoring (MoM), are to:

  • Manage and develop all assigned staff;

  • Assure hiring, training, development, compensation and advancement are in line with talent and job expectations;

  • Assess talent for direct reports to ensure full development;

  • Provide expertise and strong leadership and management to direct reports and maintains a motivated and competent staff;

  • Ensure projects/studies are resourced appropriately by allocating or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements for assigned staff;

  • Work aligned with SM CH and peers according to CDO and SM strategy;

  • Be accountable for all site management procedures and activities and ensure they are conducted according to ICH-GCP, Declaration of Helsinki, local and global requirements, remaining current with local laws, regulations and guides including country feasibility, site selection, site initiation, patient enrollment and data cleaning processes assigned to staff;

  • Ensure that each assigned staff member delivers high quality study data required to support ethical standards and regulatory submissions in compliance with global operating standards;

  • Be accountable that country's objectives and KPIs are met, providing direct reports with the resources to achieve his/her objectives and commitments;

  • Be responsible for managing costs associated with assigned staff and participate in the Country Head's preparation and tracking of the budget;

  • Oversee Corrective Actions/Preventative Actions (CAPAs) of assigned staff to ensure timely and sufficient resolution;

  • Conduct Monitoring Oversight Visits/Performance Assessment Visits for each CRA as per GSM expectations to ensure CRAs are trained appropriately and to identify potential training or development needs;

  • Participate in Audit Review Meetings and review all responses to audit findings prior to submission;

  • Collaborate effectively with vendors providing insourced resources to develop and implement training and development plan in a timely manner based on any deficiencies found or areas identified for improvement;

  • Support CH with follow up of all Regulatory Inspections, Regulatory concerns related to investigator integrity, GCP, and the veracity of all clinical data in NDA, CTD, PLA, SNDA, and IND submissions;

  • Identify and propose solutions continuously and proactively for process improvement opportunities to Country Head and communicate best practices to entire monitoring staff;

  • Participate as member of Expert Working Groups and provide feedback on Global Standard Operating Procedures (SOP) updates;

  • Identify actions to be taken at the country level to improve upon audit and inspection findings;

  • Assess all training needs for direct reports, develop and implement training and development plan in a timely manner;

  • Align local training needs and best practices with CDO Training strategy and contribute to deliver training programs;

  • Posses thorough understanding of global and local processes, drug development and associate SOPs;

  • Contribute to development of country clinical investigator network to support the portfolio needs for clinical trials;

  • Collaborate with Medical Science Liaison management to cultivate and enhance clinical investigator relationships to support business strategy;

  • Lead and manage CLMs, Senior Site Managers and Site managers to deliver high quality clinical trial data within agreed upon timelines and budget;

  • Ensure greater focus on quality, oversight and consistent performance on behalf of an embedded insourced group due to increased scrutiny of regulatory authorities on the quality of clinical trial data, and increased business demands to conduct clinical trials in an efficient manner;

  • Contribute to development of clinical investigator network within country to support portfolio needs for optimal clinical trial execution.

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:

  • Healthcare related Bachelor’s degree (or equivalent) with eight years' relevant healthcare experience including a minimum four years’ relevant clinical development or clinical operations experience;

  • Deep knowledge of Research and Development processes and local and global regulations;

  • Ability to lead staff in changing times;

  • Strong and visible leadership and management skills;

  • Decision making;

  • Issue resolution;

  • Cross-Functional collaboration;

  • Effective written and verbal English communication skills;

  • Able to work effectively within a multicultural, global, virtual, matrix organization;

  • Travel to sites, functional meetings, local and international level.

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. 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.

Location: United States : Residence Based : Residence Based

Division: Pharmaceuticals

Reference Code: 69071

Contact Us

+1 888-473-1001, option #5

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