Company DescriptionBioclinica is one of the leading global CRO company which focuses on bringing efficiency to the clinical trials. We have a premier global research network—and the only one with investigator sites in the U.S., Europe, Latin America, and Asia. We are headquartered in Doylestown, PA. Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. We serve more than 400 pharmaceutical, biotechnology, and device organizationsJob DescriptionThe Clinical Project Manager will focus on study start up through close out activities and perform project analysis while highlighting leadership skills in therapeutic areas such as Neuroscience, Musculoskeletal, Oncology, Cardiovascular, and more. This individual would be driven, dedicated and adaptable in a fast-paced environment. Project Management experience within a CRO is highly desirable. Primary ResponsibilitiesIdentifies project guidelines and communication needs by:Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documentsDefining project plans (i.e. timelines, milestones and limitations for project staff)Establishing project reporting schedulesProviding project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on scheduleCommunicating timely, appropriate project information to project teams, sites and company/sponsor representative(s)Performs project analysis and management by:Identifying critical project success factors for tracking, analysis and reportingDetermining needed resources for project completion and communicating needs to appropriate departmental managersCollaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of projectPerforming financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost managementPossessing a thorough understanding of the project contract and totals needed for monthly revenue reportingUnderstanding SOPs and working closely with QA for clarification and documentation of deviationsTraining and maintaining project team knowledge and applications of SOPsCommunicating all protocol clarifications/revisions to project teamCoordinating site management of data collection with internal and external teamsProvides project team leadership by:Leading by example with professional and collaborative conductDeveloping and delivering team project trainingEstablishing team performance expectations and guidelinesProviding input to departmental managers of respective team members’ performance levelAnalyzing team performance for consistency/quality within established project guidelinesCollaborating with the departmental managers for team coaching/mentoringSupports Business Development efforts by:Collaborating with BD Director in the development and presentation of company capabilities calls/meetingsAttending professional meeting(s) as Company representativeDelivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company servicesOversees project close out by:Assisting with coordination of submission activities, as applicableAssisting with initiating and overseeing all project close out activities to completionPerforms supervisory functions by, if applicable:Communicating job expectationsPlanning, monitoring and appraising job resultsCoaching, counseling and disciplining staffInitiating, coordinating and enforcing systems, policies and proceduresApproving direct reports time sheets, requests for time off and/or overtimePerforming timely performance evaluations of direct reportsCoordinating and conducting new hire interviews; facilitating hiring decisionTraining new hires on departmental processes and responsibilitiesMaintains Quality Service and Departmental Standards by:Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)Establishing and enforcing departmental standardsReviewing and updating company SOPs related Secondary ResponsibilitiesContributes to team effort by:Exploring new opportunities to add value to organization and departmental processesHelping others to accomplish resultsPerforming other duties as assigned and deemed necessaryMaintains Technical Knowledge by:Attending and participating in applicable company sponsored trainingQualificationsEducation:Bachelor’s degree required or commensurate experience level. Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirableExperience:Previous management or project experience in clinical development of investigational medications required1-3 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role.Working knowledge of GCH, ICH guidelines and FDA regulationsMedical Imaging experience a plusExperience working with computer software including Word, Excel, Access and Project preferredAdditional skill set:Strong interpersonal and communication skills, both verbal and writtenStrong organizational and leadership skillsGoal orientedAbility to maintain professional and positive attitudeAdditional InformationWorking conditions:Travel: 0-20%Lifting: 0-15lbsOther: Computer work for long periods of time EEO StatementBioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic