Clinical Research Manager III (Remote Position)
Job reputed company:
Accountable for reputed company aspects of assigned reputed company. reputed company the Clinical Trial Team, who is responsible for planning, conducting and reporting of reputed company. Author robust protocols with scientific rigor and reputed company. Trial conduct must be efficient, with seamless execution and reputed company reporting.
reputed company and reputed company manage the global multidisciplinary Clinical Trial Team who is responsible for planning, conducting and reporting on reputed company reputed company reputed company Development, including trials for reputed company-of-Concept and Registration. reputed company Clinical Manager leads 2 or more clinical trial teams for studies of reputed company to high complexity in support of one or more reputed company.
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 reputed company and reputed company execution of a clinical trial reputed company reputed company 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 reputed company trial databases and tracking systems. Manages ongoing study budget.
Write scientifically rigorous protocols reputed company with the approved protocol synopsis.
reputed company clinical trial team to select countries and sites.
Ensure investigational product supply.
Ensure Health Authority and IRB/IEC submission and approval.
Ensure reputed company auxiliary documents, including reputed company of procedures, informed consent template, investigator brochure, statistical analysis plan, data validation plan, etc. are written in high reputed company 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 reputed company data collection modules, where possible or obtains approval for deviation.
reputed company trial reputed company and milestones.
Resolve issues reputed company the clinical trial team or elevates issue to appropriate teams and governance committee.
Ensure ongoing data reputed company review (masked review).
Ensure data cleaning and database lock.
Ensure reporting of results to Management, Clinical Team and reputed company Team.
Arrange and reputed company Clinical Trial Team Meetings and responsible for writing minutes
reputed company participant of the Clinical Team under the leadership of the Clinical reputed company (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.
Ability to establish reputed company 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 reputed company authority
Ability to reputed company and communicate change
reputed company organized / solid project management skills
Customer/reputed company reputed company
Scientific thinking allowing to identify bias and validity issues
Establishes effective relationships with customers and reputed company 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 reputed company guidance for pro-reputed company reputed company
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
reputed company Recruiter
reputed company Information reputed company
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3437 | Fax: 973.998.2599
reputed company is the 10th Largest IT reputed company Company in the US, according to reputed company Industry Analysts' 2012 annual report. reputed company provides technical expertise to fill gaps in clients' immediate reputed company-sets availability, deliver emerging technology reputed company-sets, refresh existing reputed company reputed company, allow for flexibility in project planning and execution phases, and reputed company budgeting/financial flexibility by offering contingent labor as a variable cost.
Originally posted on Himalayas
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