Deputy Director, Clinical Data Management,Oncology Strategic Business Unit Medical & Data Management in Whippany, New Jersey | DiversityInc Careers
 

Deputy Director, Clinical Data Management,Oncology Strategic Business Unit Medical & Data Management

.pre {white-space: pre-wrap;} Your tasks and responsibilities

The primary responsibilities of this role, Deputy Director Clinical Data Management Oncology Strategic Business Unit Medical & Data Management (OSBu MDM) are to: 

 

  • Lead and manage a group of 7 to 12 direct reports, potentially including Expert Clinical Data Managers, Principal Clinical Data Managers, and Senior Clinical Data Managers allocated to one of the Clinical Data Management (CDM) sub-groups, with staff located in 1-3 locations and/or regions;
  • Represent and manage a diverse staff in a multi- cultural, global environment of research and/or clinical development;
  • Be accountable for the performance management, including annual performance planning, development dialogues, on-going progress review, feedback and performance evaluation using the Bayer Core Competency model;
  • Ensure the active participation of direct reports in ongoing data review/reconciliation activities and in the utilization of dashboards, metrics and patient trackers to monitor data arrival and clean up;
  • Ensure that Study Teams are kept appraised of data arrival and cleanup status;
  • Be responsible for the oversight and governance of a group of 5-10 insourced individuals working in an Functional Service Provider (FSP) model in a remote location;
  • Act as a key contact for external resource provider;
  • Ensure timely and high quality deliverables of external Data Management team;
  • Oversee planning, management and implementation of Research and/or Clinical Development strategy according to the agreed Clinical Development Plan (CDP) within the established timelines, budget, and quality required for strategic decision making for the overall development program and/or for multiple global regulatory submissions;
  • Ensure alignment of all activities within own sub-function with business strategy and priorities as set and communicated through the hierarchy, including the co-accountability with the Statistical Lead to create, maintain and manage the Project Plan and Integrated Data Review and Cleaning plans;
  • Ensure high quality support and contribution to relevant Research and Development driven activities.  This may include taking lead responsibility for process development, maintenance, and operative performance of particular CDM;
  • Ensure projects/studies and research driven activities (as applicable) are resourced appropriately by allocating or hiring the competent staff to deliver project/study goals;
  • Analyze project/study needs as well as manage and measure the workload requirements of direct reports;
  • Supervise operational activities of staff members; ensures proper training and identifies re-training needs of Data Management Best Practices, Standard Operating Procedures (SOPs), and relevant regulations;
  • Oversee Data Management documentation for projects/studies to ensure highest quality level;
  • Proactively support, drive and implement strategic initiatives as well as process improvements for operational activities where necessary;
  • Strive to increase efficiencies in collaboration with Research and/or Clinical Development, as well as in collaboration with other Data Science & Analytics (DS&A) and global functions;
  • Manage internal cost of up to 1.5 Million Euros. €, including resource, travel and training requirements;
  • Ensure all clinical Data Management activities are conducted with the highest ethical standards. Ensure regulations are followed, e.g., CFR, International Harmonization Committee-Good Clinical Practices (ICH-GCP), SOPs, processes etc.
  • Be accountable for awareness and adherence to all applicable compliance rules and regulations.

     

.pre {white-space: pre-wrap;} 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:

 

  • Is a leader with professional experience in the area of  oncology clinical development line management;
  • Bachelor’s degree and at least ten years’ work experience, OR Master’s degree and at least seven years’ work experience;
  • At least seven years’ of relevant healthcare experience including 4-5 years of Clinical Development Data Management experience in the pharmaceutical industry, Biotech or a CRO;
  • Three years’ of experience as line manager;
  • Good knowledge of relevant research processes, as well as ICH-GCP;
  • Solid understanding and proven experience in at least one specialized topic relevant for research or early development work (PK, Biomarker, Pharmacometrics, Bioinformatics);
  • Ability to lead staff in developing and applying new techniques as well as strong interpersonal skills in the management and development of people in a global environment.

 

Preferred Qualifications:

 

  • Leadership, motivational and interpersonal skills;

    Experience in Therapeutic Areas matching those of Bayer’s research and development activities (as examples: Cardiovascular, Women’s Healthcare);

  • Administrative, project management, and technical skills;
  • Effective verbal and written communication skills.
.pre {white-space: pre-wrap;} 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. 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.

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