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Clinical Trial Project Manager Jobs

Clinical Trial And Regulatory Manager
By ImCare Biotech At Doylestown, PA, United States
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all relevant guidance documents, and assigned study protocol(s).
Working with third party consultants as needed to manage related regulatory submissions and/or communications with the FDA.
Minimum of 5 years experience in Clinical Research
Diagnostics-related clinical study experience preferred
Experience with FDA communications/submissions, including Q-subs, 510k, and/or de novo submissions preferred.
ACRP or equivalent certification is preferred
Clinical Trial Manager Jobs
By SciPro At South San Francisco, CA, United States
**This opportunity may have future direct management responsibilities.
Manage vendor operational meetings to ensure project goals and timelines are met.
Early phase and start up experience required.
Demonstrated experience in selecting, managing, overseeing, and successfully developing effective relationships with multiple vendors and CROs.
Prior experience working in a start-up environment is a highly desired.
Responsible for study start-up, including working with cross functional teams on startup, and with the CRO on site selection/activation
Clinical Trial Manager Jobs
By Verily At Boulder, CO, United States
Experience in study project management and prior management of contracted resources/CROs.
Experience in site monitoring, clinical quality compliance and international study management.
Deep knowledge of the range of tools used in the clinical study management space.
BA/BS/BScN degree in health or biologic science, or equivalent practical experience.
Master's degree in health or biologic science, or equivalent practical experience.
Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for clinical trials.
Senior Clinical Project Manager
By Rhythm Pharmaceuticals Inc. At Boston, MA, United States
Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical Affairs to align on deliverables and execute study activities
Knowledge of global clinical trial management in CRO outsourced environment
Lead and manage integrations of all clinical study activities leveraging internal and CRO resources, expertise and knowledge
Lead the development of contingency/risk management plans and associated mitigation strategies
Manage and provide mentorship for junior clinical operations team members
Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure
Clinical Trial Manager Jobs
By Cpl Life Sciences At Ohio, United States
Minimum of 2 years of Clinical Trial Management experience within a CRO
Project Management experience desirable for Senior Clinical Trial Manager (Associate Director level)
Location: Hybrid - (Remote considered for 5+ years CTM experience with some in-person meeting requirements)
Are you an experienced Clinical Trial manager or Project manager?
Management of overall project timeline
Do you have previous Oncology, Rare Diseases or CNS experience?
Clinical Trial Manager (Contract)
By CRISPR Therapeutics At Boston, MA, United States
Demonstrated effective time management skills
Knowledge of First in Human trial management
Experience with cellular therapy trial management
Work with CRISPR financial management to reconcile monthly actual and forecast budgets
5+ years in a Clinical Operations Management role
Excellent communication, writing and presentation skills
Clinical Trial Manager Jobs
By EPM Scientific At Philadelphia, PA, United States
Minimum 3 years of CAR-T experience
Strong oral and written communication skills with ability to work with cross-functional teams
Formulate and execute operational strategies to achieve successful in-house implementation and oversight of clinical trials focused on CAR-T
Oversee all aspects of trial initiation procedures, working in coordination with other departments within Clinical Operations
Uphold adherence to regulatory requisites, encompassing ICH-GCP, FDA directives, and other pertinent regulations throughout every phase of the trial's lifecycle
A BA/BS in science related field
Clinical Project Manager Jobs
By RapidAI At ,
Operate independently across business functions in support of VP Clinical, data management, engineering, and regulatory teams.
Medical Benefits – We offer a range of policies through TriNet
Manage/coordinate marketing studies across internal functions including Clinical, Research and Product Development.
Monitor studies in accordance with regulatory requirements, Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and the Good Manufacturing Practices (GMPs).
Advanced understanding of imaging modalities (MR, CT, etc.) to help align clinical and engineering validation requirements to accelerate regulatory clearances worldwide.
Statistical analysis of development data; knowledge of diagnostic analysis techniques.
Senior Clinical Project Manager
By Seagen At , Bothell, 98021 $143,000 - $184,800 a year
Proficiency with Excel, MS Project, Contract development and vendor oversight. CRO management experience a plus.
Project Management Certification (PMP) is a plus
Reviews study metrics for performance and quality with the team and management
Prepares high-quality reports (financial, project, etc.) for management on program status and issues
Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive knowledge is preferred.
Responsible for leading clinical trial team meetings. May manage the GDT meeting and perform all required cross-functional follow-up
Global Clinical Trial Manager (Us-Remote)
By Amgen At , Thousand Oaks, 91360
Management of study budget and timelines
Management of vendors to the required standards
Global Clinical Trial Manager (US-Remote)
Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
Experience of collaborating and leading cross-functional teams in a matrix environment
Experience of managing complex projects across multiple countries and time zones
Clinical Trial Manager / Senior Clinical Trial Manager
By Repare Therapeutics At Cambridge, MA, United States
Present study status reports of operational execution activities to senior management.
Strong understanding of FDA/ICH guidelines and industry standard practices regarding clinical trial management
Leads cross-functional trial team to ensure delivery of complex clinical trials and manages protocol execution.
Excellent communication skills. Ability to communicate in an open, clear, timely and consistent manner
Clinical Trial Manager/Senior Clinical Trial Manager
Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
Project Manager – Clinical Trial Management Systems
By OSI Engineering At Oakland, CA, United States
Previous clinical trials experience in a similar role providing project management, solutions management, and IT solutions to a clinical trials program.
IT project management experience related to implementing and optimizing components in clinical trial digital ecosystems.
5+ years of experience in system design/ architecture project manager/ related position.
Provide support and manage areas of System Design/ Architecture.
Experience working with Tableau or similar analytic reporting software.
Experience working on any kind of benchmarking and/ or milestone reporting software to show metrics and progress.
Clinical Trial Manager - 98102
By Medix™ At United States
Manages CRO, including overseeing clinical monitoring, investigational selection and site management
Manages, provides guidance and oversight for all components of a clinical trial from protocol development through clinical study report
Helps develop and manage clinical budgets and contracts plans for clinical trials.
Develops and contributes to development of study plans and manuals
Collaborates with CRO and investigational sites, as needed, to complete and execute trial deliverables as required per protocol and contract.
Responsible for oversight of Trial Master File (TMF) for inspection readiness.
Clinical Trial Manager Jobs
By Iovance Biotherapeutics, Inc. At United, PA, United States
Lead role in vendor identification/qualification/selection, systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.)
Demonstrated experience in management of CROs, in vendor selection
Required Education, Skills, And Knowledge
Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
Ability to critically review and supervise a multifunctional vendor groups including clinical operations, data management and biometrics
Effectively tracks and communicate program/study progress to Senior Management with ability to create and update detailed dashboards and trackers
Clinical Trial Transparency Manager (Fully Remote) (Apply Today)
By ICON Strategic Solutions At United States
Manages the vendor interactions for the relevant submission documents
Experience with data protection, anonymization, and redaction plans set up
Redacting protocols, SAPs, CSRs and other applicable documents in support of trial transparency activities
Supporting ad-hoc trial transparency projects
Maintains and updates the rules for the personal data redaction/anonymization according to local laws and regulatory authority guidelines as applicable
Please apply today and I would be happy to tell you more.
Local Trial Manager Jobs
By DOCS At All, MO, United States

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, ...

Clinical Trial Manager Jobs
By Beacon Hill Staffing Group At Chicago, IL, United States
Prior experience in management and monitoring of CRO and investigative sites.
Manage the operation of clinical program(s) to ensure compliance with regulatory requirements.
Ensure adequacy of data acquisition and management, and timely completion of studies and associated projects.
Evaluate CROs for their ability to execute clinical trial work, compare budgets and timelines and make recommendations to senior management.
Lead/represent Clinical Affairs team, processes, programs across our company and external venues in partnership with senior management.
Maintain up-to-date knowledge of published literature in relevant therapeutic areas including the key clinical operations issues.
Global Clinical Trial Manager (Us-Remote)
By BioSpace At Thousand Oaks, CA, United States
Management of study budget and timelines
Management of vendors to the required standards
Global Clinical Trial Manager (US-Remote)
Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
Experience of collaborating and leading cross-functional teams in a matrix environment
Experience of managing complex projects across multiple countries and time zones
Clinical Trial Manager- Job Id: 1172
By Ascendis Pharma At Palo Alto, CA, United States
Experience working in a cross-functional matrix environment, CRO management and oversight, and managing and overseeing vendors
Responsible for the daily management of assigned operational aspects, such as CRO/vendor management, drug supply management, oversight of clinical sites, etc.
Develop or provide input to trial plans, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Protocol Deviation Plan, etc.
Contribute to Ascendis’ Clinical Quality Management System by authoring or contributing to clinical SOPs.
Manage and oversee Central Labs.
Lead/manage internal clinical trial teams with representation from relevant functional areas.
Clinical Trial Manager--Remote Jobs
By Eliassen Group At United States
1) 1-3 years of Clinical Trial Management experience: Candidates must have CTM experience for study management
3) 1-3 years of experience with client interactions and management
2) 1-3 years of Vendor Management – within a clinical trial.
6) Bachelor’s Degree (Scientific Field Preferred)
ASAP, interviewing as early as next week