1+ months

Sr Manager Clinical Research

Saint Paul, MN

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.


Primary Job Function

Clinical Affairs leadership position responsible for managing Clinical Shared Services Operations activities in support of clinical study budget and timelines.  Responsible for leadership and development of staff.

Core Job Responsibilities

  • Oversee the biostatistics, data management and safety operations for the clinical program
  • Lead personnel in their support of design verification and design validation studies under ICH/GCP guidelines
  • Lead the data management/systems personnel in their support of database development and management activities
  • Responsible for the review and approval of protocols; submissions that include data processes by the biostatistics group
  • Facilitates completion of safety related reports; Annual/Interim
  • Lead departmental and global process improvement initiative. Proactively seek and evaluate new systems to enhance the process of managing clinical data.
  • Independently identify, evaluate, and resolve significant medical and safety related issues in compliance with current clinical standards and relevant worldwide regulations and guidelines. Includes monitoring and reporting of safety data
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • May have budgetary responsibility for cost center or clinical program. Ensure development of accurate - study budgets, contract development and execution, payments and tracking of study expenditure.
  • - Management of personnel development, mentoring and effective delegation to direct reports to meet program goals.
  • - Effectively communicate information through the planning and execution of meetings and presentations and present recommendations to leaders. Participates in strategy development and execution for specified clinical area.
  • - Effective coordination of all functional areas involved in the clinical program to solve problems and assure progress and timely completion of program goals.
  • - Anticipate potential problems within a clinical program and create contingency plans accordingly. Elevate potential changes in regulatory or clinical environment to leadership
  • - Manage performance management process for the team.
  • - Critical review of vendor proposals and contracts to include CRO agreements to ensure program success.  Financial approval of contracts and expenses at specified level.
  • - Prioritization across teams to ensure strategic goals/milestones within Clinical Development, are met.


    Leader within the organization; demonstrates strong leadership competencies. Makes decisions and charts course through careful evaluation of risks and benefits with limited information in conjunction with director.

    Builds/drives relationships and teamwork within team and across functions with professional demeanor.

    - Develops and maintains current, in-depth, relevant functional knowledge (such as scientific, technical and regulatory aspects) of projects in support of the therapeutic area on a global basis. Builds and maintains relationships with key experts and professional organizations that further the effective development of the drug product and maximize product potential. Collaborates with functional management to ensure an appropriate functional spokesperson for the project is identified to interact with relevant stakeholders, including R&D, clinical and commercial management, external experts and professional organizations and regulatory agencies.

    - Leads and motivates functional area teams to meet key project deliverables and timelines by developing

    effective technical strategies, and collaborating with functional management to coordinate tactical execution by sub team members and functional organizations. Drives short- and long-term project success by managing and monitoring the functional components of worldwide projects such that scientific, regulatory, legal, financial, commercial and quality requirements are met in consideration of time and resource constraints as well as environmental uncertainties while operating by and within standardized procedures established within the function.

    - Uses thoroughly analyzed data, due diligence, and input from internal and external functional experts to drive a rigorous decision-making process that appropriately incorporates underlying assumptions, risks and benefits, probabilities of success, timelines, and resource requirements. Effectively manages team members and deliverables in times of conflict, uncertainty and crisis; and resolve issues in a timely manner in conjunction with functional management.

    - Fosters creative thinking, innovation, knowledge sharing and reasoned risk-taking.

    - Ensures appropriate review and refinement of project plans by functional area management and staff. Clearly communicates project/program recommendations and decisions to various stakeholders within the team, functional areas, R&D, clinical, and commercial management. Appropriately disseminates feedback from governance bodies and the functions to the team and extended organization. Acts on appropriate feedback from worldwide project team stakeholders and functional management to optimize performance as worldwide project team core team member.

    Position Accountability / Scope

    - Program/development strategy/direct line management and research matrix management

    - Clinical operational representative for worldwide project team. Daily interaction with director, project manager, directors in multiple cross-functional areas, including finance.

    - Responsible for setting direction, creating/managing budget, prioritization, staff management and

    Development within the clinical shared services team.

    Minimum Education

    Bachelor’s degree or equivalent combination of education and experience. Degree in medical or scientific field desired. Advanced degree is preferred.

    Minimum Experience / Training Required

    9+ years of direct clinical research experience with 4-6+ years of clinical research management preferred, or an equivalent combination of education and work experience.

    ** Global experience highly preferred, with focus on safety, data and statistical management.

    ** Management experience in other clinical operations positions desirable.

    ** Recognized leader in standard business procedures (SOPs, Global Regulations, OEC, Outsourcing) and the application of procedures to the business. Considered a Subject Matter Expert and key contributor to initiatives.

    ** Leader and key contributor to initiatives and advancement of Clinical Development as an organization


    Job Family: Clinical Affairs / Statistics
    Division: SH Structural Heart
    Travel: Yes, 10 % of the Time
    Medical Surveillance: Yes
    Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


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Sr Manager Clinical Research

Saint Paul, MN

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