Average salary: $191,429 /yearly
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Job Description TileDB is looking for a highly organized and proactive Executive Assistant to support our CEO, CRO, and the broader executive suite. This role is pivotal for the smooth operation of our fast-paced startup. The ideal candidate will excel...
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Holiday work
Remote job
Flexible hours
...development for biomacromolecules and small molecules
Good Manufacturing Practices (cGMP) regulations
Transferring internal methods to CRO or CMO
Drafting documents for quality support on investigations, OOS, and OOTs
Contributing to regulatory documents, including...
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Local area
Remote job
2 days per week
..."
Nice to Have
•Familiarity with Golden Gate or Gibson assembly
Interview Process:
•Multiple Panel interviews with camera on.
Position Comments visible to Supplier: Previous experience in a CRO role, preferred.
No wiggle room in the BR
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...to ensure compliance with required regulatory and ICH GCP quality standards and consistency with SOPs.
* You will partner with the CRO to lead, plan, and execute clinical Investigator meetings study meetings, as needed.
* You and your team will participate in preparation...
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...including the essential Trial Master File (TMF).
Requirements
About you:
At least 7 years of experience in the biopharma or CRO industry is required
Preferably some experience in managing clinical sites
Demonstrated excellence in managing clinical...
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...enrollment, clinical monitoring, GCP and protocol compliance, from the clinical sites, CROs and vendors.
* You will coordinate with the CRO and the Relay Tx Clinical Operations Lead to support planning from study initiation through study closure.
* You will maintain...
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...and GLP experience a plus.
Demonstrated knowledge and understanding of quality compliance principles with specific focus on GMPs (CRO compliance knowledge a plus).
Additional Experience Desired:
Biological Drug Substance production
Production of...
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...activities, data collection and reporting, and providing support as needed to the team of field champions.
* Provide input to both the CRO and internal clinical development plans for the study, and ensure study team adherence to the plans.
* Develop and manage study...
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...oversight of Contract Research Organizations (CROs) and other external vendors. Builds solid relationships with key counterparts at CRO(s) and other external vendors
•Coordinates the development and distribution of critical study documents, including Informed Consent...
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Holiday work
Contract work
Temporary work
Interim role
Flexible hours
1 day per week
...clinical trial vendors and partners such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
Leads CRO and other vendor selection and reviews contracts/work orders/change orders
Ensures inspection readiness for clinical trials...
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Holiday work
Immediate start
Flexible hours
...Some college preferred.
~ Some leadership or supervisory experience desired.
~ Experience working in pharmaceutical company or CRO strongly preferred.
~ Must have Intermediate to advance knowledge of Microsoft Office Suite, Concur, SharePoint, Visio or OrgPlus...
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Hourly pay
Contract work
Flexible hours
2 days per week
1 day per week
...development until assignment of additional clinical operations resources.
* Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations.
* Responsible for budget management for assigned programs/portfolio...
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Local area
Flexible hours
...expertise while leveraging available space.
**About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety...
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Worldwide
Flexible hours
...Minimum Requirements/Qualifications:
BS/BA or MS in a life science or analytical area with minimum 10 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation.
Previous experience leading...
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Minimum wage
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Full time
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Worldwide
...of gene-editing products
* Perform medical review of SAEs, SUSARs and aggregate safety data from all sources in collaboration with CRO medical monitors
* Lead the development of safety risk management plans, IND annual safety reports
* Develop and update RSIs for...
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...professional characteristics:
~15+ years experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO, with at least 5+ years of people management
~ Minimum B.A./B.S. degree in science/healthcare field or a nursing degree
~...
Contract work
Local area
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Work from home
Relocation package
...maintaining relationships with trial sites, monitoring/co-monitoring, managing, and closing clinical study sites
•Reviewing and overseeing CRO activities, review of monitoring reports, and monitoring vendor KPIs
•Collaborating with colleagues at all levels and in all...
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Relief
Local area
Flexible hours
...monitor for clinical trials and to ensure adherence to ICH GCP, patient safety, and data integrity, in close collaboration with the CRO medical monitor.
As appropriate, provide medical expertise for interactions with regulatory authorities, including required regulatory...
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...visit
Job Summary
This position is responsible for designing, developing, and utilizing PK and ADA assays for internal studies or CRO transfer. This individual will also weigh in on internal PK study designs and modes of drug administration studies that will help...
...in place and optimally maintained to support clinical drug development activities as well as our vendor relationships with external CRO or CMOs
* Ensures quality systems and processes are designed to be appropriate for research, development, manufacture, testing and...
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...of all project team activities, leveraging internal and development partner resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
Manages performance, development and growth of junior staff to support and guide them to...
...Establish a manufacturing development plan, execute protocols, and successfully report the development of drug candidates to our CRO/CDMOs, including the identification and implementation of appropriate manufacturing processes and equipment.
Increase internal technical...
...analysis software.
Interpret results, write up reports, and present data within the organization and at conferences.
Responsible for CRO management for activities aligned with the Imaging work.
Maintain records including electronic lab notebook.
Requirements...
Contract work
Flexible hours
...issues through the Quality Organization as needed.
GCP Vendor Audits and Oversight. S upport the GCP Vendor Audit Schedule including CRO, Central and Specialty Laboratories, IxRS/IRT/Randomization liaising with QA Vendor Auditing. Coordinate with Study Team members to...
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Part time
Remote job
...Project Management, Clinical Supply Management, and/or Pharmaceutical Development.
~ Experience in biotechnology, pharmaceutical and/or CRO industry.
~ Phase 1-3 global supply chain management experience, including first in human studies, preferably in Oncology.
~...
Contract work
Remote job
...qualification of bioanalytical assays via LC-MS/MS and immunoassays and other platforms for clinical biomarker studies
Supervise CRO activities to ensure bioanalytical method development/validation activities conducted with CROs lead to robust methods that support...
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...and study deviations
Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
Review and provide clinical operations input into relevant clinical documents such as the protocol,...
Holiday work
Flexible hours
...Ability to perform basic sample size calculations is desirable
At a minimum, possess enough familiarity to provide necessary data to a CRO Stat group for tasks such as sample size calculations, time-to-event analysis, or sensitivity analysis
Clinical Trial Activation...
Holiday work
...Requirements
Essential Requirements:
• MS equivalent in a relevant discipline with 10+ years of experience in the pharmaceutical / CRO / regulated industry
• 5 years of GCP (for laboratories) and GLP regulations experience
• Strong scientific, process, and...
Relocation bonus
...Job Description George Higginson is currently searching for a highly experienced Senior Clinical Data Manager for the up-and-coming CRO, specialising in Oncology.
The Senior Clinical Data Manager is responsible for the oversight and management of data management activities...