Lead data management activities for clinical studies from database start-up through lock, including vendor oversight and the creation of essential DM documentation. Ensure data accuracy and consistency for regulatory submissions while managing project timelines and budgets.
Codera
15 Remote Job Openings at Codera
Oversees quality programs to support product realization and inspection readiness across multiple workstreams and entities. Manages vendor assessments, batch releases, and quality risk management processes throughout the product lifecycle.
Support the clinical development strategy and execution of domestic and international drug development programs across all phases. Collaborate cross-functionally to ensure high-quality clinical data, support regulatory interactions, and oversee safety monitoring.
Oversee the planning and execution of CMC strategies and drug product formulations to support development programs. Manage relationships with CDMOs and CROs while drafting regulatory documents for IND and NDA submissions.
The Site Director manages overall clinical site operations, including identification, start-up, monitoring, and close-out of Phase I-IV studies. They ensure patient safety, data accuracy, and compliance with ICH-GCP guidelines and regulatory requirements.
The Site Director manages overall clinical site operations, including identification, start-up, monitoring, and close-out of Phase I-IV studies. They ensure patient safety, data accuracy, and compliance with ICH-GCP guidelines and local regulatory requirements.
Responsible for overall clinical site management, including identification, start-up, monitoring, and close-out of Phase I-IV studies. Ensures patient safety, data accuracy, and compliance with ICH-GCP guidelines and regulatory requirements.
Lead the operational delivery of assigned clinical studies from concept through reporting, ensuring inspection readiness and regulatory compliance. Manage study timelines, budgets, and vendor performance while collaborating across functional areas to mitigate operational risks.
Manager, Records Management (TMF Quality Control Specialist)
Codera
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Full Time
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2 months ago
Codera
The Manager ensures that Trial Master File (TMF) documents adhere to SOPs, ICH GCP guidelines, and regulatory requirements to maintain inspection readiness. They provide quality control, conduct TMF reviews, and offer training and support to study teams on documentation practices.
The Associate Director manages study start-up, site selection, and clinical operations for Phase I-IV trials in compliance with ICH-GCP guidelines. They are responsible for IRB submissions, TMF quality reviews, and overseeing the operational aspects of site activation and records management.
Oversee clinical supply chain operations, including drug supply planning, forecasting, and distribution for domestic and international studies. Manage third-party vendors and ensure compliance with GxP documentation and trial master file requirements.
The Vice President of Clinical Development will oversee the strategic planning and execution of domestic and international drug development programs. This role involves leading clinical trials, ensuring regulatory compliance, and managing medical oversight including safety and pharmacovigilance.
The Site Director is responsible for the end-to-end management of clinical sites, including site identification, study start-up, monitoring, and close-out activities. They ensure compliance with protocols, ICH-GCP guidelines, and regulatory requirements while overseeing patient safety and data integrity.
The Manager/Senior Manager, Contracts will provide organization-wide contract support across research, manufacturing, clinical, finance, and general operations, focusing on reviewing, drafting, and negotiating a wide range of agreements. This role is also responsible for managing the entire contract lifecycle, ensuring compliance, and reporting real-time status updates to management.
The Site Director, Clinical Operations is responsible for overall clinical site management, covering activities from site identification and start-up through monitoring, patient recruitment, and site close-out for clinical studies. This role ensures patient rights and data quality are maintained according to protocols, SOPs, and regulatory requirements.