Sr. Manager, Clinical Safety

Abbott Laboratories Plymouth , MN 55447

Posted 2 months ago

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Along with their team, plans and manages multiple or complex/partnership cost center or Clinical

Development Program(s) across Safety functional area, within budget and timelines. May represent clinical safety function at Advisories, interactions with Regulatory Agencies and for evaluation of business opportunities including due diligence. Responsible for leadership and development of staff.

Core Job Responsibilities

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

  • Responsible for compliance with all laws, guidelines and regulations applicable for clinical safety reporting.

  • May have budgetary responsibility for cost center or safety activity in a clinical program.

  • Ensure development of accurate Safety study Budgets and tracking of study expenditure for Safety.

  • Management of personnel development, mentoring and effective delegation to direct reports to meet program

  • 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

Position Accountability / Scope

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

  • Clinical operational representative for worldwide clinical safety team. Daily interaction with director, safety monitors and associates and, directors in multiple cross-functional areas, including finance.

  • Manages internal organization/department within larger Clinical organization in a cross-functional environment.

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

Minimum Experience / Training Required

  • 6-8 years of direct clinical research experience with 4-6 years of clinical research management preferred, or an equivalent combination of education and work experience. IDE clinical experience is highly preferred.

  • Management experience in other clinical operations positions desirable. Global experience preferred. Clinical Safety experience required.

  • 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.

Supervisory / Management Responsibilities

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

  • Manages internal organization/department within larger Clinical organization in a cross-functional environment.

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

JOB FAMILY:Clinical Affairs / Statistics

DIVISION:MD Medical Devices

LOCATION:United States > Minnesota > Plymouth : 5050 Nathan Lane N

ADDITIONAL LOCATIONS:

WORK SHIFT:Standard

TRAVEL:Yes, 20 % of the Time

MEDICAL SURVEILLANCE:Not Applicable

SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link

  • English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link

  • Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
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Sr. Manager, Clinical Safety

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