Job Details

ID #2885267
State Vermont
City Montpelier
Full-time
Salary USD TBD TBD
Source Bayer
Showed 2019-11-18
Date 2019-11-18
Deadline 2020-01-17
Category Et cetera
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Country Lead Monitor

Vermont, Montpelier 00000 Montpelier USA

Vacancy expired!

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 MonitorYOUR TASKS AND RESPONSIBILITIESThe 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 SOP compliance necessary to provide quality data required for global regulatory submissions for drug approval;

Lead the local study team, and be the main contact across other functions locally;

Ensure that the CRA team receives study specific training, identify 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 the primary liaison for CRO and ARO-run studies, for the CRO and ARO liaison role, the CLM will 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 provide credible country feedback;

Oversee feasibility activities across all studies in specific countries;

Oversee all country startup activities and contribute 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;

Proactively identify 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;

Act as 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 ensure follow up items are resolved according to SOPs / OI;

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

Act as a mentor for new or less experienced CRAs and CLMs;

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 develop a plan until resolution;

Ensure patient safety as well as quality and compliance of clinical trial data for Regulatory Approvals of a drug due to the increased scrutiny of regulatory authorities on the quality of clinical trial data, and increased business demands to conduct clinical trials in an efficient manner;

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

WHO YOU AREYour 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 five years of relevant healthcare experience including four years of monitoring and site management experience OR two years of clinical trial management experience;

Deep knowledge of R&D 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 APPLICATIONBayer 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/VeteransBayer 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 BasedDivision: PharmaceuticalsReference Code: 68415Contact Us+1 888-473-1001, option #5

Vacancy expired!

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