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Associate Project Manager (Clinical Trial - Early Phase)

Parexel International Corporation

USA - Any Region - Home Based

Parexel is looking for a remote Associate Project Manager to join our Glendale, CA Early Phase Clinical Unit! In this role you would be accountable for the successful delivery of projects and programs by delivering on time, on budget, and to the highest quality while remaining compliant with ICH, GCP, and other applicable regulations. This requires in-depth business understanding, knowledge, experience, and flexibility to make informed and effective decisions independently. By providing overall leadership of EP clinical trials, the Associate Project Manager ensures the project teams achieve operational excellence and successful execution of the clinical operations and logistical strategy.

Your Activities:Leading regular meetings/calls with sponsor to ensure they are fully informed of project progress, proactive decisions / solutions and how the project objectives are being achievedOwning the sponsor relationship and is responsible for sponsor communicationProviding a central point of study contact and single point of escalation on behalf of the functional teams (clinical, data management, biostatistics, medical writing, logistics, contracts, finance, medical and pharmacovigilance)Maintaining a positive, results-orientated work environment, building partnerships, and modeling teamwork, communicating to the team in an open, balanced, and objective mannerLeading team meetings on a regular basis with project team to ensure project objectives are metProactively communicating to team members, the scope of work, timeline and project goals, technical information, and input from sponsor throughout the project including significant changes in resourcing, scope of work and timelinesProvide proactive decisions /solutions with management support and how the project objectives are being, or should be, achievedReviewing relevant materials (e.g. request for proposal, proposal, etc.)Preparing for Bid DefensePreparing monitoring and site management strategyManaging study start up activities Escalate issues to management, finance team, account manager, and partnership office as required.Initiating the project following review of Lessons Learned to ensure current Best Practices are implementedDefining, planning, and providing oversight of site selection strategyReviewing the applicable project contract/exhibit and provide comments as appropriateReviewing initial budget to provide feedbackManaging the set-up of the project team, overseeing request for resource, reviewing proposed team members for suitability, and managing any project team changes throughout the duration of the projectInitiating and/or managing IRB/EC and RA (when applicable) approval process with relevant team membersOrganizing and lead Sponsor Initiation Meeting by establishing expectations for project delivery, communication, and sponsor specific metrics, etc.Overseeing set up and management of investigator paymentsSupporting enrollment team with patient recruitment plan and retention planCoordinating and ensuring completion of process for study insuranceWorking with the Project Assistant to set up project-specific training as needed for team membersEnsuring the project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulationsCoordinating monitors and vendors according to the monitoring plan/contractual obligations (as applicable)Preparing, participating in, and following up on audits/inspectionsManaging the project budget including providing input into revenue recognition, milestone payments and monthly pass-through invoices.Other duties as assignedQualificationsYour Profile:Bachelor’s degree in a science related field Project Management experience OR 2 to 4 years related work experience in project management or related fieldsExperience Managing multiple and varied tasks with enthusiasm, with attention to detail, strong customer focusIn-depth understanding and experience in the clinical trial processKnowledge of guidelines, ICH-GCP and other applicable local and international pharmaceutical industry regulationsSolid computer and internet skills including knowledge of MS-Office products such as Excel, Word, PowerPoint, and ProjectTravel Requirement: 20%

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medicalEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2022-06-03

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