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Bayer Country Lead Monitor-Field Based in Indianapolis, Indiana

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.

Country Lead Monitor-Field Based

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role,Country Lead Monitor (CLM), are to:

  • Be the key country study contact for the core study team and overall responsible for country deliverables regarding timelines, budget and quality for assigned studies from feasibility all the way through archiving;

  • Develop the country enrollment and retention plan, manage country site selection and initiation, country risk leveling, patient enrollment and data cleaning activities;

  • Develop contingency plans, ensure ethical, regulatory and Standard Operation Procedure compliance necessary to provide quality data required for global regulatory submissions for drug approval;

  • Be the leader of the local study team and the main contact across other functions locally;

  • Ensure that the Clinical Research Associate team receives study specific training, identifies training gaps and develops further training plans in liaison with the core study team as required;

  • Track overall country study progress to meet the country deliverables, and develop and manage mitigation planning;

  • Be assigned to be the primary liaison for CRO and ARO-run studies;

  • Be responsible to align the relevant stakeholders internally and externally, to support regulatory and country start-up activities and to coordinate quality initiatives;

  • Manage all feasibility activities and provides credible country feedback;

  • Be assigned to oversee feasibility activities across all studies;

  • Oversee all country startup activities and contributes to completion of all necessary study documents for ethics and regulatory approval for site initiation according to agreed timelines;

  • Ensure all legal, regulatory and Bayer requirements are met prior to site initiation;

  • Be responsible for the overall quality of the study in his/her country by using relevant IT systems, among other tools;

  • Identify proactively potential or actual country related issues that may impact the quality and compliance of the data, provide appropriate solutions and ensure actions are implemented;

  • Be responsible for country level corrective action / preventive action plans (CAPAs) maintenance;

  • Oversee country TMF completeness and quality, ensuring that quality checks are performed and appropriate actions are in place to ensure files are ready for Inspection and are filed in accordance with relevant SOPs, ICH GCP and regulatory guidelines;

  • Be a key contributor to the preparation, conduct and follow up of site audits and regulatory inspections to ensure a successful outcome;

  • Perform monitoring report review and ensures follow up items are resolved according to SOPs / OI;

  • Conduct regularly co-monitoring visits to ensure the quality of the study;

  • Act as a mentor for new or less experienced Clinical Research Associates and Country Lead Monitors;

  • Be assigned to specific local and global expert working groups, roles, initiatives or other activities at the discretion of the CHSM;

  • Establish proper collaboration with local functions such as medical affairs, pharmacovigilance, regulatory, legal, compliance to ensure the study is conducted in accordance to local requirements and regulation;

  • Be accountable for planning, managing and tracking local study budget in close liaison with the assigned CTPS specialist as well as the core study team;

  • Identify budget/estimate issues and proactively develops a plan until resolution;

  • Ensure patient safety as well as quality and compliance of clinical trial data for Regulatory Approvals of a drug;

  • Oversee the conduct of the country level activities to ensure the country meets committed enrollment and timelines and country study budget.

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:

  • Undergraduate degree or equivalent with at least five years of relevant healthcare experience including four years monitoring and site management experience or at least two years of clinical trial management experience;

  • Customer focus;

  • Drive Results;

  • Plan and Align;

  • Manage Complexity;

  • Build effective teams;

  • Cultivate Innovation;

  • Courage;

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

  • Project management skills;

  • Decision-making and issue resolution skills;

  • Cross-Functional collaboration;

  • Budget management;

  • Effective written and verbal English communication skills.

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 : New Jersey : Whippany || United States : Residence Based : Residence Based

Division: Pharmaceuticals

Reference Code: 300041

Contact Us

Email: hrop_usa@bayer.com

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