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VP Clinical Development

Job ID: 782
Type: Direct Hire

JOB DESCRIPTION                                                                                  



Responsible for the development of engineering and post-market clinical research to meet company objectives, advocacy of clinical evidence through presentations, publications, and speaking bureau events, and management of the company’s key opinion leader meetings.  Manages Clinical Research Associate (CRA) and Clinical Advocacy personnel toward department objectives.  Interfaces with customers, key opinion leaders, Engineering, Regulatory, Marketing, and Executive Management.  Acts as resource to internal and external customers on clinical issues.

Duties and Responsibilities:


1.    Strategy development

a.    Create a strategic map of relevant clinical study evidence by parameter / product

b.    Work closely with marketing and exec management to identify clinical study opportunities and priorities

2.    Study development

a.    Initiate and co-develop clinical study concepts with internal and external customers

b.    Identify project sites, define budgets, and time required to complete a clinical study concept

c.    Solicit and evaluate investigator-initiated research proposals

d.    Develop/approve/edit protocols, case report forms, database specifications, and statistical plan

e.    Perform a risk analysis of protocols with investigator and internal input

f.     Recruit investigators / sites

g.    Negotiate support level with investigators

h.    Ensure appropriate regulatory controls (site and patient) in place for studies

i.      Manage clinical trial agreements and internal and external review process

3.    Monitoring

a.    Conduct study start-up activities, train site personnel, conduct interim monitoring visits and study close-out visits.

b.    Monitor data collection to ensure timely completion of all studies

c.    Manage auditing mechanism to ensure data quality and protocol compliance

d.    Track and review study documents such as case report forms, source documents and adverse event forms in order to ensure completeness and accuracy

e.    Review regulatory documentation for completeness and accuracy during study initiation and maintains such documentation throughout the study

f.     Assist site personnel with data changes as needed to ensure clarity and accuracy of the data

g.    Ensure timely and accurate transfer of data into database format

h.    Ensure site adherence to the study protocol, relevant SOPs, GCP/ICH Guidelines, HIPPA, trial registration, and all other applicable regulatory guidelines

i.      Prepares monitoring reports based on each site visit

j.      Managing equipment and sensor inventory and return upon study completion

4.    Analysis and reporting

a.    Manage internal data analysis and required outside statistical analysis to meet both protocol-identified and additional investigator statistical analysis objectives

b.    Produce study results reports for internal and investigator review

c.    Conduct data review calls get gain alignment with investigators toward publication

5.    Publication planning

a.    Work with investigators to proactively identify presentation and publication targets

b.    Assist investigators toward dissemination of study results in scientific meetings and publications

6.    Clinical education

a.    Develop and manage comprehensive clinical education program for all content and geographies

b.    Propose and manage educational content, speakers, administrative, and promotion of company sponsored CME and CEU programs

c.    Recruit and manage national speakers bureau list and active program participation to drive education initiatives

d.    Deliver education programs directly at local and national venues

7.    Evidence library

a.    Manage master citations library

b.    Provide updated abstracts of presented and published data for marketing and sales use in collateral and web

8.    Key opinion leader meetings

a.    Work collaboratively with marketing and Medical Affairs to identify KOL meetings including Scientific Advisory Boards, Global Advisory Board, and select private meetings

b.    Manage meeting agendas and dissemination of information to attendees

9.    Personnel management

a.    Hire, train, and perform annual employee evaluations

b.    Manage data collection and site visit activities

c.    Assign and manage additional project objectives as necessary

10. Budget management

a.    Propose annual budge to meet company research objectives within budget growth guidelines

b.    Monitor and manages all aspects of the clinical research budget

c.    Monitor and communicate individual study and overall budget status at regular intervals

11. Functional management

a.    Develop necessary departmental procedures and evaluations

b.    Complete required reports within established timeframes

c.    Provide proactive problem solving and timely follow-up customer issues

d.    Stay professionally current and follow all procedures related to this job which can affect the quality of products or services provided to our customers

12. Education, Experience, Skills, Physical Requirements

a.    Education

                                          i.    Bachelor’s Degree (B.A. or B.S.) in engineering, science, or medical field

                                        ii.    Masters Degree (MBA, MSN, MS) or Doctorate (MD, PhD) is highly desirable

b.    Experience

                                          i.    Ten or more years of medical device, biotech, or pharma clinical research management experience

c.    Skills

                                          i.    Current knowledge and understanding of the hospital and health care environment

                                        ii.    Excellent communication and presentation skills

                                       iii.    Positive, service-oriented attitude

                                       iv.    Excellent project management skills

                                        v.    Excellent writing skills

                                       vi.    Advanced ability to use all Microsoft Office Applications

d.    Physical

                                          i.    Based out of corporate office in Irvine – person must live in Southern California

                                        ii.    Up to 25% overnight travel may be required

                                       iii.    Flexible work hours and weekend work may be required

                                       iv.    Valid California driver’s license, passport, and ability to drive to research sites



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