Katalyst CRO
Sr. Manager, Clinical Data Management
Katalyst CRO, Brisbane, California, United States, 94005
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Sr. Manager, Clinical Data Management
role at
Katalyst CRO
2 months ago Be among the first 25 applicants
Responsibilities
Reporting to the Executive Director, CDM, the Senior Manager, CDM will oversee data management activities across multiple studies, from start-up through closure, supporting clinical trial objectives and corporate goals.
Coordinate with cross-functional teams as a key member of the study team, ensuring data integrity and compliance.
Act as the main contact for all study-related data management deliverables.
Manage vendor/CRO relationships and oversee outsourced data management activities.
Ensure proper documentation and participate in study document reviews.
Oversee data flow with CROs and vendors, manage the Trial Master File, and support regulatory inspections and audits.
Contribute to the development of SOPs, work instructions, and strategic planning for the CDM department.
Stay updated on emerging trends and technologies in CDM to enhance department standards and procedures.
Minimum Requirements
Bachelor's degree with at least 8 years of relevant industry experience.
Strong attention to detail, organization, and project management skills.
Excellent communication and interpersonal skills.
Knowledge of GCP, CDISC standards, FDA and ICH guidelines, and best practices in CDM.
Proficiency in Medidata Rave or other EDC platforms.
Experience managing CROs and external vendors.
Additional Details
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Research, Analyst, and Information Technology
Industry: Pharmaceutical Manufacturing
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Sr. Manager, Clinical Data Management
role at
Katalyst CRO
2 months ago Be among the first 25 applicants
Responsibilities
Reporting to the Executive Director, CDM, the Senior Manager, CDM will oversee data management activities across multiple studies, from start-up through closure, supporting clinical trial objectives and corporate goals.
Coordinate with cross-functional teams as a key member of the study team, ensuring data integrity and compliance.
Act as the main contact for all study-related data management deliverables.
Manage vendor/CRO relationships and oversee outsourced data management activities.
Ensure proper documentation and participate in study document reviews.
Oversee data flow with CROs and vendors, manage the Trial Master File, and support regulatory inspections and audits.
Contribute to the development of SOPs, work instructions, and strategic planning for the CDM department.
Stay updated on emerging trends and technologies in CDM to enhance department standards and procedures.
Minimum Requirements
Bachelor's degree with at least 8 years of relevant industry experience.
Strong attention to detail, organization, and project management skills.
Excellent communication and interpersonal skills.
Knowledge of GCP, CDISC standards, FDA and ICH guidelines, and best practices in CDM.
Proficiency in Medidata Rave or other EDC platforms.
Experience managing CROs and external vendors.
Additional Details
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Research, Analyst, and Information Technology
Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr