Bayer Hiring for Assoc Dir Study Mgr at Helena, Montana Full Time

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Assoc Dir Study Mgr

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Associate Director Study Manager, 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 in close collaboration with study team and all clinical team members;

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

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

• Chair study team meetings and investigator meetings, lead organization of investigator meetings, holds vendor kick-off meetings;

• Develop in cooperation with respective functions appropriate study related training for 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;

• Work in more complex and/or higher priority studies, work alongside a SrStM assuming a co-study manager role;

• Support protocol feasibility;

• Lead the operational planning and tracking of the site feasibility;

• Report status, issues and important feedback to GCT;

• Support analysis of feasibility data;

• Develop study timelines including enrollment projections, milestones and proposed external study budget;

• Manage all study related activities from an approved study concept to the final Clinical Study Report (CSR) to ensure 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 throughout set-up, maintenance and closure and initiates actions to resolve issues;

• Support during Authority Inspections and internal audits and be responsible to get study conduct related findings solved;

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

• Develop the 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;

• Provide 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 enrolment, data cleaning progress and overall study progress;

• Oversee forecasting of clinical/non-clinical supplies;

• Lead study risk levelling and risk mitigation strategies;

• Contribute to risk management activities of GCT;

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

• Be responsible for study specific oversight;

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

• Work on Corrective And Preventative Action (CAPA) identification 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 manages the selection and oversight of external suppliers (e.g. CRO, Central Laboratory, Central Reading Center, etc.);

• Define outsourced tasks and develops contract specifications for 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 (incl. 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), (this is an assignment not a job title, the distribution of tasks is done based on the 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;

• Lead, motivate and inform country teams;

• Ensure training and oversight of monitoring;

• Track and report operational progress;

• Develop additional operational plans.

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 with at least seven years of relevant healthcare experience including at least three years of clinical operations in the pharmaceutical industry which includes direct monitoring and clinical trial/study management experience;

• Be responsible for management of Phase I-IV global clinical trials, this requires an in-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Conference on Harmonization-ICH regulations) with a proven track-record leading the initiation and completion of clinical studies;

• Have the ability to successfully achieve results within a multi-cultural and geographically diverse team, and be capable to create team culture and promote team spirit;

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

• Have effective written and verbal communication, thorough knowledge of oral and written English, strong oral presentation, and excellent interpersonal, decision-making and issue resolution skills;

• Have effective planning and organization skills, attention to detail and excellent follow through;

• Be able to manage conflicts in the team effectively.

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

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.

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Division: Pharmaceuticals

Reference Code: 464545

Contact Us

Email: hrop_usa@bayer.com