Clinical Project Manager - Global Recruiters of Boston North

Position Description

Company
The company is a biopharmaceutical company dedicated to bringing best-in-class critical care and hospital-based therapeutics to patients. Company’s strategy is to in-license clinical-stage drug candidates and develop them for markets with clear unmet medical needs.

DRUG CANDIDATE, our lead product, represents a promising new treatment for DIC (disseminated intravascular coagulation) in sepsis. This product might also be beneficial for a number of other indications. A product-specific DRUG CANDIDATE Program Advisory Board consisting of experts in sepsis, critical care and hematology will help guide the development and commercialization of this potentially breakthrough product.

Description
Under the direct supervision and assistance from the Sr. Director of Clinical Operations, the Clinical Project Manager is accountable for the day-to-day operations of one or more clinical trials commensurate with complexity, including trial start-up, conduct, monitoring, and close-out activities. This position will develop and implement initiatives aimed to ensure the successful and timely completion of the DRUG CANDIDATE Phase 2b clinical trials and all related clinical trial milestones, and those of other products of the Company. Our lead product, represents a promising new treatment for DIC (disseminated intravascular coagulation) in sepsis.


Responsibilities
• Provide input on the clinical study design, monitor trial progress, manage the project level budget and oversee quality assurance, managing external vendors, data management, and ensuring that reporting activities are completed.
• Direct site communication and clinical monitoring input related to product development;
• Oversee vendor training for all clinical aspects of drug development;
• Coordinate materials for clinical trials;
• Validate site-specific regulatory documents for IND and BLA filing;
• Track tasks performed by CRAs and independent contractors;
• Monitor vendor GCP audits
• Review all clinical documents.
• The CPM will have responsibility for reviewing, and creating Clinical Monitoring SOPs, managing training, and providing a leadership role in the maintenance of Clinical Operations Monitoring standards.

Requirements
• 5 – 7 Years experience required
• Bachelors degree in a scientific or health-related field, R.N. preferred
• Broad experience with all aspects of clinical monitoring and oversight of contracted resources
• Fundamental knowledge of GCP, U.S. IND, and ICH regulations.
• The CPM candidate will have at least 2 years experience leading trials and at least 5 years of clinical research experience in the biotech, pharmaceutical, or contract research organization arena, and of which at least 3 years experience as a Clinical Research Associate (CRA).
• Therapeutic knowledge in any of the following areas is desired: Sepsis, critical care, oncology, respiratory/pulmonary, or anti-invectives.
• Applicants must be highly self-motivated, with superior organizational, communication, and management skills. Travel domestic and international as much as 30% during the interim phase of the trials.

How to Apply

Application Instructions / Send a Resume