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.
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
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).
Sr. Clinical Trial Manager (12 Month Contract)
By Thrive At Carlsbad, CA, United States
Clinical Trial Manager position open for a biotechnology sponsor company
This position is 100 % REMOTE and Rates ARE VERY FLEXIBLE ***
The Sr. Clinical Trial Manager is responsible for the routine cross-functional operations of assigned studies.
● Manages the implementation, on-time execution and conduct of clinical studies.
● Manage the development of study plans, timelines, vendor selection as well as ensuring quality and compliance
● Ability to manage delegated aspects of assigned clinical trials
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.
Associate Director, Clinical Trial Diversity Operations Lead
By GSK At Collegeville, PA, United States
Manage project budgets and track progress.
Experience working directly with physicians & patients to gather insights and understand their perspectives.
Leadership experience in a matrix environment with key internal and external stakeholders & partners.
Experience with US-based & Global-based Marketing programs.
Demonstrated ability to manage multiple projects simultaneously.
Excellent communication and interpersonal skills.
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.
Sr. Clinical Trial Manager (12 Month Contract)
By Thrive At Cambridge, MA, United States
Clinical Trial Manager position open for a small-mid sized CRO company.
This position is 100 % REMOTE and Rates ARE VERY FLEXIBLE ***
The Sr. Clinical Trial Manager is responsible for the routine cross-functional operations of assigned studies.
● Manages the implementation, on-time execution and conduct of clinical studies.
● Manage the development of study plans, timelines, vendor selection as well as ensuring quality and compliance
● Ability to manage delegated aspects of assigned clinical trials
Sr. Clinical Trial Manager (12 Month Contract)
By Thrive At Seattle, WA, United States
Clinical Trial Manager position open for a small-mid sized CRO company.
This position is 100 % REMOTE and Rates ARE VERY FLEXIBLE ***
The Sr. Clinical Trial Manager is responsible for the routine cross-functional operations of assigned studies.
● Manages the implementation, on-time execution and conduct of clinical studies.
● Manage the development of study plans, timelines, vendor selection as well as ensuring quality and compliance
● Ability to manage delegated aspects of assigned clinical trials
Sr. Clinical Trial Manager (12 Month Contract)
By Thrive At South San Francisco, CA, United States
Clinical Trial Manager position open for a small-mid sized CRO company.
This position is 100 % REMOTE and Rates ARE VERY FLEXIBLE ***
The Sr. Clinical Trial Manager is responsible for the routine cross-functional operations of assigned studies.
● Manages the implementation, on-time execution and conduct of clinical studies.
● Manage the development of study plans, timelines, vendor selection as well as ensuring quality and compliance
● Ability to manage delegated aspects of assigned clinical trials
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