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Bayer Associate Director Study Management in Athens, Georgia

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.

Associate Director Study Management

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Associate Director Study Management, are to:

  • Identify, implement, lead and manage a global, cross-functional study team for the duration of the study, working with functional line management to identify team members and resolve issues;

  • Lead the yearly goal setting process for the study(ies) in scope and in close collaboration with the study team and all clinical team members;

  • Represent the study team as a member of the Global Clinical team;

  • Disseminate relevant information to the study team in an effective and timely manner;

  • Chair study team and investigator meetings and hold vendor kick-off meetings;

  • Develop, in cooperation with respective functions, appropriate study related training for the study team representatives and site personnel according to GCP and BAG pharmaceuticals development standards to ensure quality and requirements necessary for global regulatory approvals and marketing needs are met;

  • In more complex and/or higher priority studies, the Study Manager may assume a co-study manager role;

  • Support protocol feasibility and lead the operational planning and tracking of the site feasibility;

  • Report status, issues and important feedback to Global Clinical Team;

  • Support analysis of feasibility data;

  • Develop study timelines including enrollment projections, milestones and proposed external study budget based on the feasibility summary;

  • Manage all study related activities from an approved study concept to the final Clinical Study Report (CSR) to ensure the study is conducted in high quality and within the given timeline and budget;

  • Manage the possible changes in project scope, timelines, and budget;

  • Develop and implement patient recruitment and retention strategy in close collaboration with the study team;

  • Support development and implementation of integrated data review plan (IDRP) as well as ongoing data cleaning as defined in the IDRP;

  • Be responsible for set-up regular filing and completeness of study documentation (TMF)

  • Liaise with various functions to ensure seamless study conduct through set-up, maintenance, and closure and initiate actions to resolve issues;

  • Support authority inspections and internal audits, and be

  • responsible for resolving findings from study conduct;

  • Provide operational input and insight into the preparation of the study protocol and contribute to other core study documents in close collaboration with the study team;

  • Develop comprehensive overview and operational plans for the study, such as the study plan, oversight plan, etc.;

  • Measure study performance using appropriate systems, tools, and techniques;

  • Be a member of the Global Clinical Team (GCT), providing input to the GCT to enable accurate tracking and management of the overall Clinical Development Plan (CDP);

  • Establish study milestones with the study team and ensure accurate tracking and reporting of study metrics such as recruitment projections, patient enrollment, data cleaning progress and overall study progress;

  • Oversee forecasting of clinical/non-clinical supplies;

  • Lead study risk leveling and risk mitigation strategies;

  • Contribute to risk management activities of GCT;

  • Assess and analyze study information for variances and take necessary actions within his/her responsibility to resolve variances, ifnecessary;

  • Be responsible for study specific oversight;

  • Be responsible for the study risk profile, ensuring appropriate follow up of mitigation actions agreed at KOMs and FU meetings;

  • Identify Corrective and Preventative Action CAPA and follow up;

  • Be responsible for developing and tracking the total external study budget, and accountable for providing monthly, quarterly and yearly estimate information to the clinical team and to Controlling;

  • Forecast study budget in close cooperation with the Resource Management and System Integration (RMSI) group;

  • Communicate variances in the budget and action plan for resolution to the Clinical team;

  • Act as responsible outsourcing person in outsourced studies and manage the selection and oversight of external suppliers (e.g. CRO, Central Laboratory, Central Reading Center, etc.);

  • Define outsourced tasks and develop contract specifications for an external supplier in collaboration with global strategic sourcing

  • manager;

  • Liaise with quality functions to ensure vendors are qualified;

  • Perform ongoing vendor management including negotiation of scope of work, budgets (including change orders), performance management, and issue resolution;

  • Identify milestone achievements to initiate payments to vendors;

  • Act as an oversight manager if assigned to an out-sourced program under a Partnership Operational Manual (POM);

  • Ensure all relevant IT-systems are updated with current and accurate information (e.g. IMPACT, CTPS);

  • Participate in expert working groups, project standard teams, etc.;

  • Contribute to global process improvement efforts;

  • Execute clinical trials within budget, on time, and according to all relevant, internal and external quality regulations in order to achieveregulatory approval with subsequent marketing authorization for newdrugs.

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:

  • Bachelor’s degree or equivalent education and at least seven years of relevant healthcare experience, including three years of experience in clinical operations in the pharmaceutical industry including direct monitoring and clinical trial/study management experience;

  • In-depth knowledge of Good Clinical Practices (GCP), Federal regulations and international regulations (International Conference on Harmonization-ICH regulations);

  • Proven track-record leading the initiation and completion of clinical studies;

  • Ability to successfully achieve results within a multi-cultural and geography diverse team, and capability to create a team culture and promote team spirit;

  • Comprehensive knowledge of the drug development process including monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters;

  • Effective written and verbal communication skills;

  • Thorough knowledge of oral and written English language;

  • Strong oral presentation, excellent interpersonal, decision-making, and issue resolution skills;

  • Effective planning and organization skills, attention to detail and excellent follow-through;

  • Effectively manage conflict in a team environment.

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: 143343

Contact Us

+1 888-473-1001, option #5

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