Clinical Project Manager

Clinical Project Manager

Medical Affairs (MA) plays a critical role in new product development, including Key Opinion Leader engagement on innovative technologies; user needs, requirements, and hazard identification, all to ensure product safety and efficacy. MA also contributes significantly to post-market risk estimation criteria, risk-benefit analysis of products, Clinical Evaluation Reports, and literature searches.

Reporting within Specimen Management Clinical Operations Medical Affairs, the Clinical Project Manager is responsible for Human Subject Research trial management (clinical, non-clinical, and administrative functions) across multiple studies. This individual may serve as a subject matter expert for a group or platform of assigned clinical studies, including planning, implementation, oversight, project management, and completion of Human Subject Research conducted by Specimen Management (SM) Medical Affairs or a Contract Research Organization (CRO), if applicable.

As the project lead for studies of moderate to high complexity, from protocol development through study conduct and closeout, the Clinical Project Manager ensures compliance with Good Clinical Practices and all Global, National, and Local Regulations. The role collaborates with cross-functional teams, including Data Management, Statistics, and other members of the SM Medical Affairs team, to evaluate and/or develop clinical studies.

This position may directly or indirectly (matrix) manage professional employees, business support, or technical staff.

• Prepares and/orreviewsstudy-relatedoressentialstudystart-updocumentsastheyrelatetothe assigned human subject research trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, and other relevant study plans and charters)
• Servesasa Sr.Clinical Project Manager ensuring  thatthe
  
  Study
  
  Management teammeetsorexceeds the timelines and deliverables assigned to the study team.
• Responsibleforschedulingandrunningstudyteammeetingsandgenerationofmeetingminutes and other study-related documentation.
• Oversees/leads study-specificstudymanagementresources.
• Accountableforsettingownworkdirectionandcompletingworktasksassignedbyleadershipteam.
• Developsandmanagesgroupofstudiesforanentirebusinessunitorlargedevelopmentprogram.
• Providescriticalthinkingandleadershipwhenissuesariseduringexecutionofclinicalstudies, including risk management and mitigation actions.
• Leadsorcontributestocontinuousimprovementactivities/initiatives.
• Managesrelationshipswithsites/PIsandotherstudyrelatedvendors,including
  
  CRO’s
• Intermediate knowledge, of established project management standards used to develop and maintainintegratedprojectplans(scope/work packages,time/schedule,cost/materialandhuman resource, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed.
• Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, progress,risks,criticalpathandotherkeydeliverablesincludingefficiencyandeffectivenessofplans and staff.
• Adaptsworkpackagedeliverablesbasedonstudyscaleandcomplexity.
• Createsaggressivebutachievableresourceandbudgetforecastsandtimelines.
• Hasaccountabilityforgoodstewardshipoffinancialresourcesforpersonalandprojectexpenses.
• Interacts with both Internal and External contacts, providing direction to the Global Clinical Affairs (GCA) cross functional teammembersandvendors(if applicable) regardingthetechnical,protocol-specificandoperational aspects of assigned studies.
• Proactivelyidentifiesandmanagesrisksandissues(includingalog,mitigations,and contingencies) to ensure cost effective timely delivery of the project, including escalations, as needed.
• Plansandmaintainshighqualitystandardsinordertomeetcompliancerequirements.
• Performsotherdutiesandassignmentsasrequired.

• Abilitytoexerciseindependentjudgmentanddiscretionwithinabroadlydefinedrangeofpolicies and practices. This includes analytical problem solving.
• Demonstratedabilitytojugglemultipletasksandtoprioritizeandscheduleworktomeetbusinessneeds.
• Demonstrated or…