Clinical Trials Management Associate

CTMA -Late Phase plays vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects.

Responsibilities:
Non-Client sponsored studies:

· Serves as the key operational contact with external investigators and internal stakeholders.

· Able to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety elements and implications.

· Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements and financial or Client product support are processed in a timely manner and to high quality.

· Proactively identifies operational challenges and in collaboration with senior team members provides and implements solutions to ensure study remains on track.

· Maintains efficient collaboration with company’s Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in timely manner.

· Supports study drug planning and shipping activities with Materials & Logistics.

· Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.

· Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.

· Provides monthly study updates to the appropriate internal stakeholders.

· Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.

· Implements working processes to promote high quality, efficient, and compliant systems for Late Phase research management.

· Supports and implements Clinical Operations Quality Initiatives.

· Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.

· Performs administrative duties in a timely manner as assigned.

May contribute to Client sponsored studies:

· Monitors fairly routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.

· Under supervision may assist in development and review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.

· May assist in compilation of investigator brochures under close supervision.

· Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.

· Travel might be required.

· Skills required demonstrating key Client core values of Integrity, Teamwork, Excellence, and Accountability

· Excellent planning, time management, organizational, and administrative skills.

· Demonstrates core values of strong team work and accountability with ability to prioritize competing timelines and deliver excellent results

· Learning ability with demonstrated flexibility required to maintain a fast pace

· Effective communication skills, both oral and written and interpersonal and presentation skills.

· Tenacity and perseverance to ensure high level customer service.

· Teamwork is a mandatory requirement as it involves building and maintaining internal/external networking and cross-functional collaboration.

· High sense of urgency and commitment to excellence in the successful execution of deliverables.

· Must be able to prioritize multiple tasks, and accomplish goals using well-defined instructions and procedures.

· Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials, and ability to understand clinical study protocols a plus

· Must be proficient with MS Word, PowerPoint, Outlook, and Excel.

· Must be familiar with routine medical/scientific terminology

· Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.

· Must be able to contribute to SOP development.

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.

Thank you.

Kind Regards,

Harris Kaushik

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - (650)-399-0891

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)