Abbott Sr Manager Clinical Research in St. Paul, Minnesota
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.
NO REMOTE - THIS POSITION IS AN IN HOUSE ROLE
Primary Job Function
Clinical Affairs leadership position responsible for managing Clinical Study Operations activities in support of clinical study budget and timelines. This position will be responsible for hiring, training, developing and retaining qualified Clinical Research Associates (CRA’s) and Clinical Study Coordinators (CSC’s) and managing resource allocation to study teams. Responsible for the oversight, development and performance of CRA’s/CSC’s and assures that quality of services meets internal and external customer needs. The Clinical Research Manager must also exercise judgement in planning and organizing CRA/CSC workload; monitor performance, set goals and objectives and track progress. They are also responsible for continuous process improvement and training within the clinical organization.
Core Job Responsibilities
Responsible for hiring, training and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development.
Accountable for the development of direct reports through performance reviews, instruction, mentoring, and coaching. Address low performing employees utilizing Corrective Action Plans in collaboration with Human Resources and Legal.
Accountable for the performance and work output of direct reports. Set goals and objectives which align with study team goals.
Assigns appropriate clinical personnel to clinical studies in collaboration with study project managers as applicable.
Facilitates collaborative environment through team building activities and leadership.
Models optimum leadership competencies to inspire an energized, empowered, and accountable work force, ethical behavior, favorable community image, and actualization of the Abbott Core Values.
Leads departmental and global process improvement initiatives
Partners with Human Resource Business Partner(s) to address personnel issues as they arise.
Utilizes available and/or develop tools to track work output and appropriately balance workload amongst the team.
Ensures new hires are. trained in Abbott policies and procedures, Clinical Data Systems, Clinical Process/Procedures, and study specific topics.
Maintains positive and cooperative communications and collaboration with all levels of employees, and customers.
Collaborate with cross-functional partners to identify need for additional training and to create/refine processes that impact study/CRA/CSC conduct.
Maintains an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about Abbott devices and therapies.
Provides input to Standard Operating Procedures (SOPs) and Work Instruction (WI’s).
Remains current on developments in field(s) of expertise, regulatory requirements as well as industry trends and ensures staff is trained regarding changing regulations that affect clinical investigations.
May help facilitates completion of study related reports; E.g. Annual/Interim
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
May have budgetary responsibility for cost center or clinical program including development of accurate study budgets, contract development and execution, payments and tracking of study expenditure.
Effectively communicates 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 assures progress and timely completion of program goals.
Anticipates potential problems within a clinical program and create contingency plans accordingly. Elevate potential changes in regulatory or clinical environment to leadership
Critical review of vendor proposals and contracts to include CRO agreements to ensure program success. Financial approval of contracts and expenses at specified level.
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(s).
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.
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.
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 management.
Acts on appropriate feedback from global project team stakeholders and functional management to optimize performance.
Position Accountability / Scope
Program/development strategy/direct line management and research matrix management
Clinical operational representative for global study operations team. Daily interaction with clinical directors, project managers, and directors in multiple cross-functional areas, including finance.
Responsible for setting direction, creating/managing budget, prioritization, staff management and
- 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, or an equivalent combination of education and work experience.
Previous experience managing direct reports
Global experience highly preferred
Recognized leader in standard business procedures (SOPs, Global Regulations, 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
Must have strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem-solving skills.
Able to meet deadlines and work effectively with all levels of employees.
Proficiency in Microsoft Office Suite and relevant clinical applications.
The ability to work independently
Must be able to perform in a diverse cross-functional team environment.
Experience working in a broader enterprise/cross division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
Ability to work effectively within a team in a fast-paced changing environment.
Multi-tasks, prioritizes and meets deadlines in timely manner.
- Advanced degree preferred with an academic focus in natural science, nursing, bioengineering or a related academic field.
NO REMOTE - THIS POSITION IS AN IN HOUSE ROLE
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org