[Remote] Sr. Clinical Project Manager (Specimen Management)

Remote Full-time
Note: The job is a remote job and is open to candidates in USA. BD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Senior Clinical Project Manager (Specimen Management) is responsible for managing clinical trials, overseeing project execution, and mentoring other Clinical Project Managers while ensuring compliance with regulatory standards.ResponsibilitiesWorks without appreciable supervision and direction, Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Monitoring Plan, Clinical Product Management Plan, Clinical Safety Management Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant documents)Serves as a Clinical Project Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study teamOversees/leads study-specific study management resourcesDevelops and manages group of studies for an entire business unit or large development programMentors other Clinical Project ManagersProvides critical thinking and leadership when issues arise during execution of clinical studiesWrites protocols, clinical study reports and other clinical study deliverables as applicableLeads or gives to continuous improvement activities/initiativesHandles relationships with sites/PIs, other study related vendors, including CROsIntermediate knowledge, of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resources, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as neededDefines, tracks and reports schedule attributes such as durations, interdependencies, achievements, critical path and other key deliverables including efficiency and effectiveness of plans and staffAdapts work package deliverables based on study scale and complexityCreates bold but achievable resource and budget forecasts and timelinesInteracts with both Internal and External representatives, providing direction to the cross functional team members and vendors (if applicable) regarding the technical, protocol-specific and operational aspects of assigned studiesProactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost-effective and timely delivery of the project including critical issues if neededPlans and maintains high quality standards to meet compliance requirementsAll other duties as assignedSkillsBachelor's degree, preferably in the life sciences, clinical or other relevant technical areasMinimum of 5 years of clinical study experience (pharmaceutical, medical device, IVD, biotechnology, or CRO), with proven ability to lead cross‑functional clinical teams in the planning, execution, oversight, and reporting of complex, global, multicenter studies—from initiation through closeoutMinimum of 5 years project management experience, preferably using MS ProjectStrong knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulatory requirementsMust have hands‑on experience managing the Trial Master File (TMF), ensuring accuracy, completeness, timeliness, and ongoing inspection‑readiness in compliance with ICH‑GCP and regulatory standardsProven ability to influence cross-functional teams without formal authority and collaborate with others to meet project goals, timelines, and/or deliverablesPossesses strong financial acumen, including the ability to develop and maintain accurate project budgets, forecast financial needs, and provide strategic recommendations to enhance project performance and profitabilityProven successful project management skills with meticulous attention to detailStrong client and vendor relationship management skillsAbility to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environmentExceptional written and verbal communication skills, with strong interpersonal, negotiation, and relationship‑management abilities to effectively engage a wide range of audiences and drive objectivesExpert-level knowledge of clinical operations procedures, with the ability to resolve complex, cross-functional issues and influence outcomes beyond the immediate teamExceptional problem-solving, organizational, analytical, and critical thinking abilities, with a proven track record of delivering innovative solutionsStrong leadership skills with the ability to inspire teams and drive meaningful change across the organizationProven ability to build strong relationships and communicate effectively across all organizational levels and with customers, fostering cross‑functional collaboration, proactively escalating issues, and leading joint initiatives to ensure timely resolution and project success aligned with strategic objectivesProficiency in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams) with expert-level Excel skills (Pivot Tables, VLOOKUP)Proven ability to work effectively and collaboratively in a remote environmentAbility to travel approximately 20%, should reside near a major airport to facilitate travelsAdvanced degree desirable (e.g., MS, MBA, PhD, MPH, PharmD, MD)PMP certification highly desirableExperience in technical and/or medical writing desiredBenefitsAnnual BonusMedical coverageHealth Savings AccountsFlexible Spending AccountsDental coverageVision coverageHospital Care InsuranceCritical Illness InsuranceAccidental Injury InsuranceLife and AD&D insuranceShort-term disability coverageLong-term disability insuranceLong-term care with life insuranceAnxiety management programWellness incentivesSleep improvement programDiabetes management programVirtual physical therapyEmotional/mental health support programsWeight management programsGastrointestinal health programSubstance use management programMusculoskeletal surgery, cancer treatment, and bariatric surgery benefitBD 401(k) PlanBD Deferred Compensation and Restoration Plan529 College Savings PlanFinancial counselingBaxter Credit Union (BCU)Daily PayCollege financial aid and application guidancePaid time off (PTO), including all required State leavesEducational assistance/tuition reimbursementMetLife Legal PlanGroup auto and home insurancePet insuranceCommuter benefitsDiscounts on products and servicesAcademic Achievement ScholarshipService Recognition AwardsEmployer matching donationWorkplace accommodationsAdoption assistanceBackup day care and eldercareSupport for neurodivergent adults, children, and caregiversCaregiving assistance for elderly and special needs individualsEmployee Assistance Program (EAP)Paid Parental LeaveSupport for fertility, birthing, postpartum, and age-related hormonal changesBereavement leavesMilitary leavePersonal leaveFamily and Medical Leave (FML)Jury and Witness Duty LeaveCompany OverviewBD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions. It was founded in 1897, and is headquartered in Franklin Lakes, New Jersey, USA, with a workforce of 10001+ employees. Its website is https://www.bd.com.Company H1B SponsorshipBD has a track record of offering H1B sponsorships, with 66 in 2023, 4 in 2022, 3 in 2021. Please note that this does not guarantee sponsorship for this specific role.

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