Medical Monitor Director

Over all clinical development progression and both quality and timely delivery of projects.

Driving projects through clinical development.

Be responsible for study design, protocol development, all medical aspects of study conduct, data analysis and interpretation, and reporting.

Maintain up-to-date knowledge of new scientific developments in the therapeutic area. Develops and presents Clinical Plans to governing bodies.

Responsible for high quality, current and timely medical input into sections of key planning documents relevant to area of responsibility including operational planning documents.

In partnership with the Clinical Project Director/Manager, insures indication meets timelines, milestones, deliverables and quality.

Responsible for communication of key clinical assumptions, risks and mitigation strategies.

Supports Clinical Leader in strategic thinking relevant to clinical representation on governing bodies

Ensure medical monitoring of all trials, including ongoing review of safety data from all clinical trials and adherence to regulatory guidelines and timelines for clinical study safety reporting, in conjunction with Medical Safety and Regulatory groups.

Ensures quality of review and interpretation of study data across indication/project and efficacy and safety data following data analysis.

Provides medical input, review, and approval of Investigator's Brochures, clinical study reports, integrated summaries, and other clinical documents for regulatory submission including review of analysis plans and report shells in accordance with established processes and timelines.

Work with commercial group colleagues on publication planning, opinion leader development, congress activities and advisory board support.

Provide functional management, coaching and professional development for Project Physicians and Clinical Scientists.

Lead multi-disciplinary working groups..

The medical monitor will be primarily responsible for study sites in Indiaand other Asian countries. Travel: 15-25% of time.

Qualifications/Experience:
Education level: MD

Prior experience in clinical research or related field Special skills:

Excellent oral and written communication; analytical skills to interpret clinical data, identify gaps and inconsistencies and explain how to correct/prevent in the future.

Experience with large studies in Oncology (pref Breast Cancer).

To find out more about Real Staffing please visit www.realstaffing.com