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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.
Your tasks and responsibilities
The primary responsibilities of this role, Deputy Director, are to:
+ Directly manage and develop 8-12 staff combined of Clinical Lead Monitor (CLM), Clinical Research Associate (CRA)/Senior Clinical Research Associate/SrCRA and /or Managers of Monitoring and/or Team Leaders;
+ Assure hiring, training, development, compensation and advancement are in line with talent and job expectations;
+ Routinely assess talent for direct reports to ensure full development;
+ Provide expertise, strong leadership and management to direct reports and maintain a motivated and competent staff;
+ Ensure projects/studies are properly and strategically resourced by allocating or hiring the appropriate staff to deliver relevant goals and by critically analyzing project/study needs and managing/measuring the workload and requirements of direct reports. These activities are done in close alignment with GSM CH /RH and peers;
+ Be accountable that all monitoring and site management procedures and activities are conducted according to ICH-GCP, Declaration of Helsinki, local and global requirements of applicable Phase I -IV clinical trials, remaining current with local laws, regulations and guide lines. This includes country feasibility, site selection, site initiation, patient enrollment, patient adverse event reporting and data cleaning processes direct reports are responsible for assuring that each direct report delivers high quality study data required to support regulatory submissions in compliance with ethical and global operating standards;
+ Through effective management and development of direct reports (including insourced staff through vendors), be accountable that country's objectives are met, providing direct reports with the resources to achieve his/her objectives and commitments;
+ Be responsible for managing internal costs associated with direct reports (including insourced staff), and contributes in preparation tracking and meeting of the overall departmental operating budget target;
+ Ensure CLM provide accurate data for External Clinical Grants;
+ Review External Clinical Grants data to ensure budgeting components are within the approved budget parameters, as well as ensuring accuracy, equity and supporting the CLM in resolving any discrepancies;
+ Ensure Quality Oversight based on quality risk indicators and Key Performance Indicator(KPI )and oversee Corrective Actions / Preventive Actions (CAPAs) of direct reports to ensure timely and sufficient resolution;
+ Conduct/Coordinate Performance Assessment Visits to ensure CRA are trained appropriately and to identify potential training or development needs;
+ Participate in Audit Review Meetings and coordinate and review all responses to audit findings prior to submission;
+ Proactively identify actions to be taken at the country level to improve upon audit and inspection findings;
+ Actively support Sponsor regulatory inspection in cooperation with CH/RH;
+ Supports CH/RH with follow-up of all Regulatory Inspections, Regulatory concerns related to investigator integrity, GCP and the veracity of all clinical data in New Drug Application(NDA), Common Technical Documents(CTD), PLA, SNDA and Invesgative New Drug( IND) submissions;
+ Continuously and proactively identify and propose solutions for process improvement opportunities to CH/RH GSM, and communicate best practices to entire monitoring staff;
+ Lead or participate in local and international Expert Working Groups, provides feedback during Standard Operating Procedure( SOP) review;
+ Develop and implement strategies to engage and influence external stakeholders at all levels (Principle Investigators, Institution, Government) to develop the territories and establish positive and competitive environment for clinical trials (cost effectiveness, recruitment strategies speed of trials);
+ Collaborate with Medical Affairs and commercial Business Units and other pertinent local functions to cultivate and enhance clinical investigator taught Leader relationships to ensure that Bayer is the sponsor of choice as well as to support business strategy;
+ Assess all training needs for permanent and insourced staff, develop and implement training and development plan in a timely manner;
+ Align local training needs and best practices with GCDO Training strategy;
+ Contribute to delivering Training programs developed by GCDO ICH-GCP Training. Require thorough understanding of GCD global and local processes and associated Global Standard Operating procedures (GSOP);
+ Ensure country oversight, engagement and partnership of CRO for outsourced studies ensuring CRO's adherence to country legal requirements and operational agreements;
+ Periodically cover the GSM CH/RH deputy role.
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:
+ Bachelor's degree with at least 9 years healthcare experience including at least 5 years 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 skill;
+ Ability to lead staff in changing times as well as strong interpersonal skills and at least 5 years experience in the management and development of people;
+ Administrative, financial, and technical skills, as well as effective verbal and written English 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.
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.