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.
Clinical Research Manager
Your tasks and responsibilities
- Directly manages and develops 8-12 Sr. Site managers and Site Managers. Assures hiring, training, development, compensation and advancement are in line with talent and job expectations. Through effective management and development of direct reports, the Manager of Monitoring & Site Management ensures quality and compliance as well as ensuring country's objectives are met. Provides 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 of direct reports. These activities are done in close alignment with Country Head and peers.
- Accountable for all operational activities related to global and country procedures applied in the site management of applicable Phase I and Phase II-IV clinical trials. This includes feasibility, site selection, site initiation, patient enrollment and data cleaning processes direct reports are responsible for. Assures that each direct report delivershigh quality study data required to support ethical standards and regulatory submissions in compliance with global operating standards.
- Quality Oversight - Oversees CAPAs of direct reports to ensure timely and sufficient resolution. Conducts Monitoring Oversight Visits for each Site Manager to ensure Site Managers are trained appropriately and to identify potential training or development needs. Participates in Audit Review Meetings and reviews all responses to audit findingsprior to submission. Develops and implements training and development plan in a timely manner based on any deficiencies found or areas for improvement.
- Continuously and proactively identifies and proposes solutions
- The incumbent is a highly successful candidate with extensive professional and academic experience. Key competencies needed by the candidate include the following:
- Bachelor's degree (or equivalent) with 6 years' relevant healthcare experience including 4-6 years' relevant clinical development or clinical operations experience
- In-depth knowledge of clinical development and drug development process, global clinical development processes, ICH-GCP, applicable legal, compliance and regulatory requirements
- Leadership, motivational, and collaborative skills are critical.
- Ability to lead staff in changing times as well asstrong interpersonal skills in the management and development of people in a global environment
- Administrative, financial, and technical skills are required, as well as effective verbal and written Englis communication skills in relation to both internal and external colleagues
- Able to work effectively within a multi-cultural, global, matrix organization
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.
Functional Area: [sap_fa_16]
Entry Level: 5