Register
Recruit Create CV

Clinical Trial Disclosure 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.
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 Disclosure Associate
By Randstad USA At North Chicago, IL, United States
Identifies conflicts and resolves or elevates them to management to ensure resolution.
2 years of writing experience preferred
Completes activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
Communicates deliverables, process and timelines effectively across functional areas and within department to accomplish project objectives.
Coordinates the review, approval, and other appropriate functions.
Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.
Clinical Trial Disclosure Associate (Clinical Trial Registries)
By Rangam At United States
Identifies conflicts and resolves or elevates them to management to ensure resolution.
Responsibilities will vary based upon business need.
2 years of writing experience preferred
Candidates can be remote, located anywhere in the US.
Completes activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
Communicates deliverables, process and timelines effectively across functional areas and within department to accomplish project objectives.
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).
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
Clinical Trial Manager Jobs
By Invivyd At Waltham, MA, United States
Coordinate and lead study team meetings and update Clinical Operations management on timelines and progress toward milestones.
Participate in selection and management / oversight of external vendors; develop vendor specifications; review vendor reports, budgets and forecasts, and metrics.
Independent study management of phase 1 and 2 studies at sponsor company or a CRO
Strong oral and written communication skills
Ability to work remotely and independently under general direction in a fast-paced and dynamic environment
Coordinate activities and provide oversight of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives.
Clinical Trial Contract Manager
By Mindlance At United States
·Experience of Study Management within a pharmaceutical or clinical background
·Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management
o Manager would like to see candidates with Clinical Research experience.
·Understanding of multiple aspects within Study Management
Pricing and Contract Strategy Manager
o Looking for someone that has experience that has negotiating contact language and budgets with clinical contracts.