Sr.Clinical Data Manager Job at cGxPServe, Atlanta, GA

TkI3UndwaXlCUWFiYmE4OVdZNHFkbC9aUkE9PQ==
  • cGxPServe
  • Atlanta, GA

Job Description

Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc. Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO Drug; and complete data base lock, archival, and closeout activities. Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks. Provide study level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities. Collaborate with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities. Provide program/study level oversight and expertise for CDM activities for multiple studies Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns. Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video-endoscopies, CT scans. Evaluate and manage CROs and external technology vendors to meet company's goals and CDM standards. Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor. Make decisions and chart course through careful evaluation of risks and benefits with limited information in conjunction with leadership; serve as the interdepartmental subject matter expert for the CDM area. Evaluate and manage CROs and external technology vendors to meet company's goals and clinical data management quality standards on an ongoing basis. Assist with routine quality audits as applicable. Requirements: ~ Bachelor's Degree in scientific discipline (RN or advanced degree preferred). ~9 years' industry experience in CDM in all study phases and activities from startup to archival with at least 5 years in lead role for clinical development programs with medical devices leading toward FDA filing / approvals. ~ Thorough knowledge of the CDM standards for medical devices (Class III PMA devices preferred). ~ Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats. ~ Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials. ~ Working knowledge of the MedDRA and WHODrug dictionary coding terms Able to complete tasks independently, accurately and efficiently with attention to detail and in a timely manger. ~ Experience in implementing, validating, and administrating other clinical systems for data collection (e.g., eSource, IVRS, IWRS, core lab web-based portals). ~ Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks. ~ Excellent verbal and written communication skills.

Job Tags

Similar Jobs

Oregon School Employees Association

Government Relations Specialist Job at Oregon School Employees Association

 ...Association (OSEA) is accepting resumes from individuals who are interested in working for a labor organization in the capacity of government relations specialist. OSEA currently has one government relations specialist position open. The Oregon School Employees Association... 

York E Manufacturing

Lumpers Job at York E Manufacturing

 ...with various departments to ensure smooth workflow and communication. Participate in team meetings and contribute ideas for process improvements. Maintain organized records and documentation as required. Provide exceptional customer service and respond to... 

Red Bull

Merchandiser (Part Time) Job at Red Bull

 ...with customers. RESPONSIBILITIES Areas that play to your strengths All the responsibilities we'll trust you with: Ensure RedBull products are rotated and maintained following product rotation standards thereby minimizing Out of Code and Damaged Product... 

Salganik Vision Group

Optical Lab Manager Job at Salganik Vision Group

We are seeking a dedicated and knowledgeable Optical Laboratory Manager to oversee and perform the daily operations in our optical lab. The ideal candidate must possess a strong background & expertise in an optical laboratory setting. This role requires a keen understanding... 

Honda Dev. and Mfg. of Am.,LLC

Production Equipment Robot Simulation Group Leader Job at Honda Dev. and Mfg. of Am.,LLC

 ...Bachelor of Science degree in related engineering field or equivalent technical work experience.8+ years of experience of developing industrial automation systemsExperience leading teams or groupsExperience performing robot offline programming is requiredExperience with...