ClinForce, Inc. is currently seeking a Clinical Study Manager for the New York City, NY area.
Successful candidate will take on high level responsibilities in a large, international
clinical trials. Will collaborate in the selection, negotiation and management of the CRO(s).
Collaborate with clinician in protocol development and investigator selection. Coordinate
interdisciplinary activities involving study start up: investigator meeting planning, case
report form development, study drug supply design, development of contracts and budgets, data
base set-up, and regulatory document filing. Will also oversee pre-site, initiation,
monitoring and close-out visits ensuring good clinical practice compliance according to
FDA/GCP, ICH guidelines and Company SOPs. Assure timely and correct reporting of serious
adverse events and safety data: contribute to Annual Report. Manage all aspects of study
progress and closure to assure adherence to intended time line including enrollment, clinical
supplies, data delivery and payments.
Experience/Minimum Requirements: Three to four years Clinical Research experience including a
minimum of three years in the pharmaceutical industry with involvement in all key areas of a
clinical trial; Demonstration of proficiency as Clinical Study Manager; Ability to
strategically plan, organize and manage multifaceted projects; Demonstration of strong
negotiation, communication, and interpersonal skills;CRO management training; project
management and staff management skills; knowledge of oversight and auditing processes;
excellent presentation skills
Education/Degree: BA/BS in biological sciences preferred
Interested candidates should send resumes to firstname.lastname@example.org for fax to 866-941-1400
with 'CF1185 MON' in the subject line.