Clinical Trials Management Associate - III

Company Description

Job Description

• Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas.

• With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.

• Assures site compliance with the routine protocol and regulatory requirements and quality of data.

• Assists in the setting and updating of study timelines. Assists in CRO or vendor selection.

• With guidance from supervisor coordinates CROs or vendors. Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.

• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.

• Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.

• May participate in abstract presentations, oral presentations and manuscript development.

• Interfaces with individuals in other functional areas to address routine study issues.

• May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.

• Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.

• Travel is required. Excellent verbal, written, interpersonal and presentation skills are required.

• Working knowledge and experience with Word, PowerPoint and Excel.

• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.

Qualifications

• At least 8+ years of experience and a BS or BA in a relevant scientific discipline

• At least 8+ years of relevant experience and a MS degree

Additional Information

• Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams, ability to manage staff and mentor junior staff is required

• Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required

• Thorough knowledge and understanding of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCPs governing the conduct of clinical trials and non-interventional studies