Medical Affairs - Project Manager
Covidien - Boulder, CO

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ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2012 revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70 countries, and its products are sold in over 140 countries. Whatever your specialty or ambitions, you can make a difference at Covidien – both in the lives of others and your career.

We are an affirmative action/equal opportunity employer.

SUMMARY OF POSITION :

Acts as clinical project lead, managing all aspects of multiple clinical research projects by planning, developing, and writing clinical protocols; creating and updating study documents; recruiting and training investigators; organizing and participating in investigator and FDA meetings; interfacing with investigators, site coordinators, field clinical personnel, and sales representatives; analyze clinical progress reports for scientific and technical accuracy; prepare clinical reports.

ESSENTIAL FUNCTIONS :
  • Oversee all operational aspects of multiple clinical research projects, to support corporate and departmental objectives.
  • Provide direction, development, subject matter expertise and support to Clinical Research Associates.
  • Ensure clinical research programs are conducted in accordance with company standard operating procedures (SOPs), Good Clinical Practice (GCP), and specific country regulations, as applicable.
  • Write clinical protocols for domestic and international submission.
  • Develop project plans, program budgets and study tracking tools.
  • Assist in data analysis and preparation of clinical reports.
  • Develop training materials for clinical affairs personnel.
  • Participate in organizing and planning of investigator meetings.
  • Participate in FDA meetings to further support IDE or PMA process.
  • Select, interview, and recruit investigational sites to participate in clinical studies.
  • Coordinate monitoring of study sites.
  • Assist investigators in preparation of applicable publications.
  • Attend study procedures to ensure protocol compliance and provide device support as needed.
  • Serve as technical resource to investigators, sales representatives, and other staff members regarding investigational products and protocol.
  • Gather input from cross-functional teams and create plans that help the team produce deliverables on schedule.
  • Provide clinical and technical feedback to design and development groups.
  • Assume supervisory responsibility as needed. May be directly responsible to manage Clinical Research Associates.
  • Perform other clinical duties when requested.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS : Other duties as assigned with or without accommodation.

MINIMUM REQUIREMENTS :

EDUCATION AND EXPERIENCE:
  • A minimum of a Bachelor’s Degree in Life Science (Animal Science, Biology, Physiology, Nursing, Medical Technology) plus 8 years relevant experience which includes five (5) years experience in medical device/drug customer relations, clinical research
  • Master’s degree with a demonstrated research background is preferred.
  • Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Procedures (GMP) is preferred.
  • Prior participation in all facets of clinical studies and prior supervisory experience required.
  • Strong technical or clinical background required.

PREFERRED SKILLS/QUALIFICATIONS:
  • Effective written and verbal communication skills in the area of technical/clinical applications. Strong command of medical and surgical terminology.
  • Demonstrated ability to persuasively influence external medical professionals to ensure project deliverables are completed on time and within budget.
  • Effective analytical and problem solving.
  • Ability to coordinate and lead multiple projects simultaneously.
  • Knowledge of FDA regulations concerning the conduct of pre-clinical and clinical studies.
  • Knowledge of international regulations for clinical studies.
  • Effective knowledge in searching medical literature and databases for clinical and technical information.
  • Familiarity with biostatistics techniques and methods.
  • Effective skills in MS Excel, PowerPoint, Word and internet search engines.
  • Excellent computer skills and knowledge of computerized databases for the maintenance of scientific data.
  • Working knowledge of statistics and statistical methods.
  • Strong command of Good Laboratory Practice (GLP) regulations.
  • Ability to train others.
  • Ability to work with a minimum of supervision.
  • Ability to work in a highly matrixed team environment.

Skills/Competencies:
  • Ethics and Values
  • Functional Technical Skills
  • Customer Focused
  • Interpersonal Savvy
  • Managing and Measuring Work
  • Building Effective Teams

ORGANIZATIONAL RELATIONSHIPS/SCOPE : Reports to Manager, Director or Sr Director of Clinical Affairs. Member of cross-functional project teams, collaborating with all other departments to meet clinical timelines.

WORKING CONDITIONS : Some travel would be required for site training, surgery coverage, technical support, and educational seminars. (ability to travel approximately 35-50%)

DISCLAIMER : The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers...