Biomedical Search Consultants
Senior Director/Vice
President, Clinical Research (Greater
Our client was founded in 2004 to provide dramatic
advancements in patient care by utilizing imaging technology to create
personalized, patient-specific implants and instrumentation. Currently our
client is a leader in the emerging category of patient-specific medical
implants in the orthopedic field.
The Sr. Dir/VP is a new position reporting directly to the Sr. Vice President, Regulatory and
Clinical. Initially this position will
be a hands-on role with a longer term goal of hiring additional staff to
support the role.
Responsibilities:
·
Direct the conduct of current and planned orthopedic clinical
trials, including investigator recruitment, managing data flow, clinical
quality assurance and data review
·
Assist in the development and preparation of clinical protocols,
with input from medical and technical staff
·
Develop appropriate case report forms and other study related
documents
·
Act as liaison with IRBs, Ethics Committees, etc. to assure timely
compliance with all requirements, approval of new investigational sites, etc.
·
Act as liaison with outside data management services
·
Prepare reports, slides, presentation of clinical data as needed
·
Act as liaison with, and direct, CRO in
·
Plan and implement policies, procedures, practices, and strategies
for the Regulatory Affairs Division
Required Qualifications:
·
RN or BA/BS in an appropriate field of study, advanced degree
desirable
·
A minimum of 5 years of clinical research experience (10+
preferred) that includes administrative/site management responsibility
·
A “hands on” attitude
·
Experience in small company environment a plus
·
Strong computer skills (Microsoft Office)
·
Basic understanding of statistical principles
·
Strong familiarity with GCP and ICH Guidelines for clinical trials
·
Ability to work independently in a small company environment
·
Orthopedic background a strong plus
·
Excellent project management skills with strong attention to
detail
Please submit resume to: kprovost@biomedicalsearchconsultants.com
For more information, please visit www.biomedicalsearchconsultants.com