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Principal Program Integration Manager

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

 

The primary responsibilities of this role, Principal Program Integration Manager, are to:

 

  • Assist with monitoring CI&A quality improvement and efficiency including identifying opportunities to meet and exceed performance targets;
  • Responsible for ensuring a consistent, harmonized implementation of data specifications, CDM systems, data and reporting in CI&A systems and ensure the interoperability of all study data through these systems;
  • Prepare and ensure agreement on content and timelines for CI&A deliverables during study set up, execution, TLF delivery and study closeout;
  • Document, and track deliverables in the CI&A Tracking SharePoint as communicated to customers;
  • Perform risk based and impact analysis on assigned portfolio projects and provide updates to various consumers;
  • Facilitate requirements gathering from CI&A and P&O colleagues and coordinate solution for data capture, cleaning and processing;
  • Monitor data flow concepts, adjustable study planning execution and data integrity from study start-up to post closure activities;
  • Work with technical colleagues on implementation, corrective and preventative actions, as required;
  • Contribute to the team approach, scope, best practices and responsibilities within CI&A;
  • Understand key clinical trial management roles around data acquisition and processing, statistical analysis and supporting clinical information technologies that support study monitoring and reporting;
  • Understand the activities at the compound, study, and cross study level, including data transformation programming, support of data review activities for study medical experts and data management, and oversight of data exchange with external parties;
  • Understand the operational acquisition of clinical data to ensure that the eCRF and/or eCOA tool(s) contains the necessary data to establish the safety and efficacy of the compound being tested Understanding of the process of analyzing clinical data from multiple sources, such as clinical studies, pooled data from various studies, data from CRO partners and from external epidemiology databases;
  • Meet regularly with Process Integration Manager or Integration Expert to ensure adequate communication and support to all GDS&A;
  • Contribute to the team approach, scope, best practices and defined team responsibilities.

 

 

.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:

 

  • Bachelor’s degree (or equivalent) in Natural or Life Sciences, Computer Science, Informatics or Business Process related degree;
  • At least 8+ years of HealthCare Industry experience with recent experience in Program/Process/Change Management;
  • Strong communication skills (both verbal and written);
  • Excellence in global cooperation with partnering functional heads;
  • Proven record of successful participation in teams or groups in an intercultural setting;
    • Strong Project management skills, ability to manage globally diverse team members (i.e., highly virtual) to execute key milestones on time;
    • Proficient in Microsoft Office Applications (with a focus on Word, MS Project, PowerPoint);
    • Knowledge of common Data Standards (E.g., CDISC, CDASH, SDTM);
    • Understanding of clinical data management (CDM) systems and processes;
    • Understanding of CTM/CDM suite of tools/platforms;
  • Ability to:
    • Manage to a specific and detailed multi-dependency compound/project/program deliverables plan
    • Align and manage stakeholders, as well as influence decision makers and stakeholders
    • Manage quality through Risk & Issue Management
    • Create, Plan and Lead the Execution of process workshops, meetings and training for Compound and Study Set-up, Execution, TLF’s (SET) team;
      • Strong leadership skills, ability to lead and manage compound team activities by leveraging relationships with key internal/external customers to support business and providing oversight to ensure continuous communication and alignment of major CI&A sub-functions;
      • Working knowledge of the drug development lifecycle focused on data supporting events around the following areas:
  • Study Start Up
  • Study Build
  • Study Execution
  • Study Close
.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.