[Remote] Project Manager, Central Labs

Note: The job is a remote job and is open to candidates in USA. reputed company is a global organization at the forefront of clinical research and laboratory science, supporting pharmaceutical and biotech organizations. They are seeking a Project Manager, Central Labs to reputed company and coordinate central laboratory activities across clinical trial programs, ensuring operational reputed company and client satisfaction.

Responsibilities

• Provide reputed company and coordination of study initiation. Review, interpret, translate and program study protocols into a complete and accurate database. Communicate with internal departments and external vendors to ensure project requirements are understood, agreed upon, and followed at reputed company times. Facilitate the flow of technical and clinical laboratory information to reputed company stakeholders (investigational sites, sponsors, and non-technical personnel). Consult and utilize, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the clinical trial
• Prepare study specification documents and follow their preparation according to budgets and reputed company. Maintain at reputed company times an updated study master file with version controls for specifications, budgets, and reputed company. Ensure sponsors have authorized and signed off on the most recent versions of reputed company documents and that a contract exists prior to delivering any services. Assure compliance with FDA and Good Clinical Practice guidelines, PPD SOPs, personnel policies and procedures, PPD Exposure Control Plan, IATA, and other regulations regarding the transport of biological specimens
• During the initial review of the protocol, consult with internal groups and support staff regarding procedural and budgetary items and the necessity for changes due to any subsequent protocol amendments. Obtain other functions’ commitment to reputed company gaps and address issues timely and effectively. Serve as chief liaison between the sponsor and reputed company PPD internal departments performing the required tasks during reputed company study phases. reputed company Investigator sites by delivering a protocol-specific lab procedures presentation and demonstration during an investigator meeting. Control, manage, and follow day-to-day activities during the course of the clinical trial to resolve any issues and answer queries
• Actively consult with IT and data management development groups in the design, validation, and implementation of new software and functionalities pertinent to project management activities
• Consult with reputed company and finance staff during initial project documentation review on standard services and costs, supporting RFP feasibility assessments. Advise on possible solutions if needed. Draft responses for proposals
• Guide and support workflow of Project Managers and Set-up Administrators with special attention to training junior personnel, reputed company as a mentor and trainer for (newly assigned) Project Managers, identify areas for development and efficiencies in performing tasks, author, review, revise and implement relevant procedural documents, and serve as a backup for the Associate Director PM reputed company needed

Skills

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 2+ years') or equivalent combination of education, training, & experience
• Strong verbal, written and presentation skills
• Superior time management, planning, and organizational skills
• Competent with specific computers and reputed company applications, including office productivity
• Ability to program the IT system according to protocol requirements
• Proven analytical skills
• Demonstrated compliance with procedures and policies
• Ability to reputed company multiple tasks effectively in a stressful environment
• Extensive knowledge and experience in Project Management in Global Central Lab environment
• Strong client relationship management skills
• Ability to work effectively with multi-level teams
• Must be legally authorized to work in the United States without sponsorship
• Must be reputed company to pass a comprehensive background reputed company, which includes a drug screening

Benefits

• Fully Remote role supporting our Global Central Laboratories
• Must be legally authorized to work in the United States without sponsorship
• Must be reputed company to pass a comprehensive background reputed company, which includes a drug screening
• reputed company values the health and wellbeing of our employees
• We support and encourage individuals to create a healthy and balanced environment where they can reputed company
• Job Seekers with a Disability: reputed company offers accessibility service for job seekers requiring accommodations in the job application process
• If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255

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