Clinical Project Manager

The Project Manager leads the Parexel and Sponsor teams by combining a depth of clinical research experience and project management skills with insight into sponsor pressures and an ability to develop the right solution for each sponsor. 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 or programs, the Project Manager ensures the project teams achieve operational excellence and successful execution of the clinical operations and logistical strategy. The Project Manager is accountable for the successful delivery of projects/programs (on time, on budget, to the highest quality) compliant with ICH, GCP, and other applicable documents and regulations.

The Project Manager is accountable for the financial aspects of project(s) including input into revenue recognition, milestone payments, and monthly pass through invoices. Fully understands and ensures compliance with relevant SOPs, contract terms, system requirements and metrics. The Project Manager

oversees Project Assistants to assure development of the project plan, team lists, and maintenance of

central files /regulatory files.Owns the sponsor relationship and is responsible for sponsor communicationProvides 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)Proactively communicate with the sponsor and internal groups ensuringPrioritize effectively and respond to urgent requests within team or from sponsorMaintain a positive, results-orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective mannerCommunicate to Line Managers any needs or concerns regarding level of training or performance of any team memberCommunicate fiscal, contractual, resource, deliverable and sponsor-related issues /or Regional Client Director or Sr. management as appropriateAccountable for sponsor satisfaction as measured by client survey responses and repeat business Pre-award Activities (as required)Review relevant materials (e.g. request for proposal, proposal, etc.)Attend strategy meetings and provide inputPrepare for Bid DefensePrepare project management strategyPrepare monitoring and site management strategyAttend the Bid Defense MeetingAttend relevant handover meetings on award

Leadership skills that include ability to:Lead a virtual team across locations and culturesNegotiate and influence with diplomacy in order to achieve resultsMake decisions even in ambiguous situations to achieve project timelines and qualityProactively identify and solve problems by using a logical, systematic approachConduct root cause analysis in business problem solving and process improvement developmentGain trust and confidence with a sponsor as well as within ParexelEnlist the support of team members in meeting goalsManage multiple and varied tasks with enthusiasm, with attention to detail, strong customer focus, ability to interact professionallyEffective time management in order to meet daily metrics or team objectivesPersonal skills that include:Ability to take initiative and work independentlyAbility to successfully work in a team environmentSense of urgency in completing assigned tasksCommitment to high quality work and respective consistent performanceExcellent interpersonal, oral and written communication skillsIndependent learning abilityAction orientedQualificationsKnowledge and Experience:Approximately 2 years Project Management experience with Parexel or 3 to 5 years related workexperience in project management or related fieldsExperience as Functional Team Leader in clinical/data management/logistics functions or provenexperience in coordinating clinical trialsPresentation, speaking skills (business development experience desirable)Budget/Contract experience desirableKnowledge of guidelines, ICH-GCP and other applicable local and international pharmaceutical industryregulationsSolid computer and internet skills including knowledge of MS-Office products such as Excel, Word,PowerPoint, and Project

Education:BA degree with 1 to 2 years related work experience as a clinical research project manager.Advanced degree preferred.Additional Business degree or PMP or equivalent an advantageScientific/Medical/Pharmacology background an advantageEEO 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.