Clinical Trial Manager

Kps-Life; Malvern (Chester County); On-site; USD 120,000 - 160,000; Full time

Job summary

Kps-Life is seeking a Clinical Trial Manager to lead cross-functional study teams ensuring timely, compliant delivery of clinical research deliverables. You will oversee startup, conduct, close-out, and vendor oversight while ensuring adherence to GCP, FDA requirements, and SOPs.

The role demands strong leadership, stakeholder communication, and proven ability to manage CROs, develop study processes, and maintain project timelines across multiple studies.

Qualifications

• BS degree in biology, allied health, nursing or related life science preferred.
• 5+ years related experience in clinical study execution.
• Experience leading a study or significant participation on a study team through major milestones.
• Experience managing CROs and other external providers.
• Strong ability to develop study processes and oversee study design and execution.
• Proven skills in cultivating relationships with healthcare professionals and cross-functional teams.

Responsibilities

• Lead cross-functional study teams to deliver clinical research deliverables on time, within budget and with quality.
• Oversee study operational plan startup, conduct, close-out and vendor oversight with regulatory and SOP adherence.
• Develop and apply standardized processes, metrics and tools to improve study operations and performance.

Skills

Clinical trial management

GCP knowledge

Regulatory compliance

Stakeholder communication

Vendor management

Timeline development

Cross-functional collaboration

Study leadership

Education

BS in biology/allied health/nursing/life science

Tools

CTMS

eDC

eTMF

Job description

The Clinical Trial Manager (CTM) is responsible for study team leadership in one or more cross functional study teams to deliver clinical research study deliverables on time, within budget and with good quality in compliance with Regulatory Authorities’ regulations/ICH GCP guidelines and applicable SOPs. This role collaborates and interacts with the Clinical Study Team and oversees the functional duties of the study and CRA team.

TheCTM will:

• be responsible for the oversight of the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders includingadherencetoallrelevantregulationsincludingGCP,ICHandRegulatoryrequirements,aswellas applicable SOPs and policies.
• processinputfromkeystakeholders,communicatingtotheclinicalteam,as appropriate.
• support the development and application of standardized operational study processes, methodologies, appropriatequalityandperformancemetricsandtoolstosystematizecontinuousprocessimprovement and impart best practices across clinical operations to maximize its effectiveness.

TheCTM will have:

• in-depthknowledgeofclinicaldrugdevelopmentprocessesandexperienceapplyingGCP,ICHandFDA requirements.
• solidknowledgeofclinicalresearchstudyprotocolandprocesses;abilitytoincorporateandadhereto GCP and regulatory standards. Ability to develop study processes in support of a clinical study design.
• demonstratedsolidknowledgeinseveralareasrelatedtoclinicalresearch:humananatomy,subject protection, regulatory requirements, study design, study execution.
• demonstratedskillsinimplementingtoolsforeffectivestudymanagement,identifyingand implementing solutions to address study issues, overcoming obstacles.
• demonstratedskillsincultivatingrelationshipswithhealthcareprofessionalsandcross-functionallywith co-workers from both the Sponsor and KPS teams
• demonstratedskillsinmaintainingcomposureandidentifyingandadaptingtoshiftingprioritiesand competing demands
• The ability to generate concise summaries for different audiences, professional correspondence, presentations, reports, and training materials.
• Literacyinwordprocessing,spreadsheets,anddatabasesapplications(e.g.,MSWordand Excel).
• Skilledatdevelopingprojecttimelinesandmilestonesandworkingwithteamtoensuremilestonesare met; adjusts appropriately when needed and communicates risks when necessary.
• strongcommunicationskillstobeabletodiscusswiththePrincipalandSub-Investigatorsandtheirsite staff, even in challenging situations such as recruitment, protocol deviations and oversight.

TheCTM will have:

• BSdegreeinbiology,alliedhealth,nursingorrelatedlifescience preferred.
• 5ormoreyearsrelatedexperienceinclinicalstudy execution.
• experienceleadingastudyorsignificantparticipationonstudyteamthroughmajor milestones.
• experiencemanagingothersasdirectsupervisorand/orleaderofmatrixclinicaltrialteam preferred.
• experiencemanagingCROsandotherexternal providers.
• system experience preferred: (i.e. CTMS, eDC, eTMF etc.).