Clinical Trials Manager

The selected candidate will manage the operational aspects of clinical trials including protocol development, investigator recruitment, patient enrollment, study specific guidelines/processes, and quality of data collection. Participate in determining outsourcing strategy and vendor selection. Maintain knowledge of relevant regulations and guidelines and ensure compliance with GCP standards, applicable regulations, Standard Operating Procedures (SOPs), and study specific documents, processes, policies, and procedures and meet quality and timeline metrics. Coordinate and ensure consistency of study specific templates/guidelines. Assure quality and integrity of clinical trial data and that monitoring visits are scheduled at appropriate time intervals and adjusted to manage various patient accrual rates. Assure that CRAs manage accurate data collection and appropriately handle query resolution. Track data query rates; identifying and providing solutions for data trends. Develop and initiates feasibility studies and patient recruitment strategies. Ensure adherence to timelines and budget. May develop and manage clinical budget and develop contingency plans for clinical trials. Coordinate investigator meetings and development of presentation materials. Foster positive working relationships with key investigators, opinion leaders and collaborators. Prepare and presents project information at internal and external meetings. May draft or revise clinical SOPs.

Qualifications include A BA, BS, or BSN within a scientific discipline or equivalent combination of education and work experience is required along with a minimum of six years related experience. Experience as a Clinical Research Associate should account for approximately four of the six years required. Strong medical/science background and global trial experience preferred. Knowledge of GCP/FDA/ICH regulations required. Superior communication and organizational skills in addition to the technical skills required for overseeing clinical studies. Strong organizational, planning and follow-through skills. Demonstrated leadership skills in a multi-disciplinary team environment. Ability to effectively interact with all levels of management. Ability to work well under pressure and with tight schedules. Ability to resolve problems positively and professionally. Have an in-depth understanding of clinical research. Working knowledge of MS Word, Excel and Powerpoint. Excellent language and grammar skills, ability to write clearly and concisely. Attention to detail and the ability to prioritize. Ability to exercise judgment within generally defined practices and policies for obtaining data.

Must be able to travel approximately ten percent of time with overnight stays both domestic and internationally.
How to Apply:
Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: jobs@genquestbio.com

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