Posted: March 14, 2008: Clinical Trial Manager

Job Summary

The Clinical Trials Manager will provide in-house support for clinical trial operations including management of Clinical Research Organizations (CROs) and clinical investigative sites, assisting with pharmacovigilance, maintaining appropriate in-house trial documentation and providing general support for the clinical and regulatory activities of the company. May involve both pediatric and adult studies in multiple phases of development. Reports to the Vice President, Clinical Development.

Job Duties

• Works closely with principle investigators, site clinical research coordinators, and study staff to ensure smooth operation and documentation of trials under Good Clinical Practice (GCP) guidelines.
• Manages and audits CRO in all activities related to clinical operations, including site management, data management, and pharmacovigilance.
• Visits investigator sites to assess facility/staff, initiate protocols, and ensure compliance with protocol specifications, making recommendations as warranted. Documents observations in reports and letters as needed.
• Coordinates trial site selection; investigator meetings; and study initiation, monitoring, and closure activities.
• Assists with development of study documents.
• Participates in the safety and review process of ongoing clinical trials. Co-monitors Adverse Events and Serious Adverse Events that occur in clinical trials, coordinates presentation of information to safety review committees, and ensures notification of appropriate clinical and regulatory agencies in a timely fashion.
• Participates in and/or coordinates the preparation of IND safety reports and other clinical regulatory documents for filing with the FDA.
• Reviews regulatory documents and maintains required study files (Trial Master File, etc) in-house.
• Tracks site performance and overall study progress during trials.
• Tracks study drug and other study-specific material shipments to/from sites.
• Assists QA with writing and maintaining Clinical Standard Operating Procedures in keeping with GCP guidelines.
• Complies with all applicable policies regarding health, safety and environmental policies.

Job Requirements

• RN, BSN, or Bachelors degree in a scientific discipline and 5 + years experience in clinical trials; or equivalent
• Must have working knowledge of FDA regulatory requirements
• Excellent communication skills, including presentation and writing skills
• Good interpersonal skills; ability to actively maintain good professional relationships with diplomacy and poise
• Ability to solve problems in difficult situations
• Knowledge of and experience with IND safety report is desired
• Must be able to travel 10-20% of time

Résumés and CVs may be forwarded via e-mail only to hr@glycomimetics.com. Submissions via facsimile or US Post will not be considered.

GlycoMimetics, Inc. is an equal opportunity employer.