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Job Description:
Accountable for all aspects of assigned clinical trials. Lead the Clinical Trial Team, who is responsible for planning, conducting and reporting of clinical trials. Author robust protocols with scientific rigor and quality. Trial conduct must be efficient, with seamless execution and timely reporting.
Lead and matrix manage the global multidisciplinary Clinical Trial Team who is responsible for planning, conducting and reporting on all clinical trials within Development, including trials for Proof-of-Concept and Registration. Each Clinical Manager leads 2 or more clinical trial teams for studies of medium to high complexity in support of one or more projects.
Contribute medical/scientific/feasibility input for the development of the protocol synopsis. Collaborate with the Medical Advisors to ensure country feedback is adequately integrated into the protocol.
Independently ensure quality and timely execution of a clinical trial within timeline and budget
Forecast trial resource needs. Accountable for the development, management and tracking of trial budget. Obtains approval for trial budget. Accountable for accuracy of trial information in all trial databases and tracking systems. Manages ongoing study budget.
Write scientifically rigorous protocols aligned with the approved protocol synopsis.
Lead clinical trial team to select countries and sites.
Ensure investigational product supply.
Ensure Health Authority and IRB/IEC submission and approval.
Ensure all auxiliary documents, including manual of procedures, informed consent template, investigator brochure, statistical analysis plan, data validation plan, etc. are written in high quality and available.
Define clinical outsourcing specifications for clinical trial vendors (labs, reading centers, etc.). Work with Procurement to identify vendors.
Define scope of work and contract requirements for clinical trial vendors. Oversees vendor conduct of tasks.
Ensure implementation of standard data collection modules, where possible or obtains approval for deviation.
Track trial progress and milestones.
Resolve issues within the clinical trial team or elevates issue to appropriate teams and governance committee.
Ensure ongoing data quality review (masked review).
Ensure data cleaning and database lock.
Ensure reporting of results to Management, Clinical Team and Core Team.
Arrange and lead Clinical Trial Team Meetings and responsible for writing minutes Active participant of the Clinical Team under the leadership of the Clinical Lead (CL).
Contribute to the development of clinical sections of regulatory documents like Investigators Brochures, briefing packets, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
Responsible for implementation of best practices and standards for trial management, including sharing lessons learned.
Skills:
Ability to establish clear directions and set stretch objectives
Aligns and energizes team members behind common objectives
Excellent people and communication skills
Organizational awareness to operate in a cross-functional team
Builds support from others in situations with no direct authority
Ability to embrace and communicate change
Well organized / solid project management skills
Customer/Quality Focus
Scientific thinking allowing to identify bias and validity issues
Establishes effective relationships with customers and gains their trust and respect
Conduct of clinical studies
Experience in running clinical studies independently without significant supervision
Ability to proactively identify issues, respond appropriately and provide guidance for pro-active resolution
Solid understanding of the clinical trial regulations (GCP, FDA, EMA, ICH, ISO etc.)
Education:
University degree in Medical Science or equivalent education required. Advanced degrees (e.g., MD, PhD, O.D., PharmD) are preferred.
9+ years in clinical research or relevant scientific, industry, therapeutic or geographic experience Relevant industry experience includes experience in planning and execution of clinical studies in various phases and geographies Solid understanding of the integrated development process of medical devices and/or pharmaceuticals Warm Regards
Neha Sharma
Lead Recruiter
Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: 973.967.3437 | Fax: 973.998.2599
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
