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WHAT
IN
Sr Clinical Research Manager
Job
Medtronic
US
-
Santa Rosa,
California
Job Code - 68654
Position - Full Time - Regular
Job First Active on: Monday, October 26, 2009
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JOB DESCRIPTION: Sr Clinical Research Manager
Sr Clinical Research Manager
Position Description:
Responsible for leadership of multiple clinical programs with minimal supervision. Accountable for coordination of cross-functional activities from the development of global clinical strategies for assigned products (s) to final program deliverables (e.g., reports, presentations, regulatory submissions). Develop and lead department initiatives that lead to increased efficiency, quality and cost effectiveness for the entire department to ensure best industry standards & approaches. Has supervisory responsibility for clinical research personnel.
REQUIREMENTS - QUALIFICATIONS: Sr Clinical Research Manager
Project Management: Responsible for the development and execution of comprehensive and data driven project plans, which include clinical strategy, timelines, budgets, product, resource requirements, risk assessment and mitigation plans. Ensures the programs are continuously evaluated against plan and ensure the appropriate and timely implementation of corrective action/recovery plans to ensure project success. Communicate project status frequently to all relevant stakeholders.
Budgets: Responsible for ensuring the development of accurately forecasted clinical budgets, management to the approved plan and timely payments to study centers / vendors.
Resources: Ensure projects are resourced with appropriate level of talent/expertise and financial balance of internal and external resources to ensure project success.
Quality/Compliance: Ensure studies are designed, conducted and reported according to all applicable regulations, GCP and company policies, and the highest quality/ethical standards.
Outsourcing: Ensures appropriate clinical input into the selection, contracting, negotiation of scope of work and performance management of CROs/Core labs.
Product: Ensures optimal utilization, accurate forecasting and management of clinical product across all studies in assigned programs. Ensures product complaint handling is performed in accordance with study and company procedures.
Data Management/Analysis/Reporting: In collaboration with BDM and Safety, ensures that study data are collected, cleaned, analyzed and reported according to plan and to the highest quality standards. This includes ensure appropriate clinical input of deliverables such as CRFs, SAPs, Data Management Plans, and CEC/DMC manual of operations, Safety reports, Annual Reports and final reports.
Relationship Management: Develops and maintains effective, positive and mutually rewarding working relationships with internal (e.g., Safety, Process Excellence, Biostats and Data Management, Clinical Contracts and Alliance Management, Quality, R&D, Finance, Information Management, Regulatory, and Marketing) and external customers (Regulatory bodies, Key Opinion Leaders Advisory boards, Lead PIs, Investigators, study coordinators, CROs). Implements feedback from internal and external customers to ensure needs are met.
Process: Identifies and leads department initiatives that result in resolution of clinical issues and increased operational efficiency, quality and cost effectiveness for the clinical research department to ensure best industry standards & approaches.
People: Lead a broad segment of clinical research staff to ensure clinical project deliverables are achieved. Creates a positive work environment by encouraging customer focus, mutual respect, accountability and exceptional performance at all levels. Responsible for the supervision of assigned staff according to the company policies/applicable regulations and management, including departmentally aligned goal setting, creation of development plans, training, mentoring and coaching to optimize performance.
Requirements
Education
Bachelor’s degree in a scientific discipline or equivalent
Knowledge
Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology and execution.
Thorough understanding of International Conference on Harmonization (ICH), Good Clinical Practices (GCP), safety and data management requirements, clinical trials management, regulatory compliance (including individual global/country directives/regulations as necessary) and reporting.
Experience
Requires a minimum of 9 years of experience in clinical research; cardiovascular and medical device experience strongly preferred
Successful experience managing multiple clinical trials from start to finish, including development and execution of comprehensive project plans, timelines, resource and budget planning and management.
Experience leading clinical teams in a matrix environment.
Solid experience working with contract research organizations.
Experience in performance management of clinical personnel of various levels of experience, with the appropriate demonstrated supervisory skills (minimum of 3 years experience in a supervisory role).
Skills
Highly developed leadership skills to build and direct clinical project teams to ensure that timeline, cost, and quality metrics are met
Proactive and critical evaluation of all aspects of clinical development to ensure accountability at multiple levels.
Ability to work with a continued focus on quality, efficiency and ongoing improvement
Effective written and verbal communication skills necessary to meet the needs of various audiences.
Strong problem solving, decision making, prioritization and organizational skills
Ability to lead and motivate others
Accountable, proactive, flexible and dependable.
Travel up to 30%
Medtronics
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