Tim Mcglocklin Email & Phone Number

Columbus, Oh, Us

Columbus, Ohio, United States

Provide quality oversight of Veeva Services project implementations in the clinical domain (e.g., CDMS, RTSM, ePRO). Quality and compliance oversight over GCP projects encompasses process review and regulatory alignment, GCP incident response (serious breach notifications), as well as project compliance monitoring and auditing during study conduct.

Columbus, Ohio, United States

Ensure seamless process integration across the quality spectrum and provide quality oversight in key regulated areas such as document management, change management, computer system validation, and deviation/investigation management.

Support the Quality Assurance Unit by facilitation of client/regulatory agency audits, and CAPA (corrective & preventive action) management. Conduct internal audits of key process areas. Perform regulatory assessments of product offerings.

Columbus, Ohio Area

- Provide oversight to processes and procedures in the development of EDC systems with a focus on GCP compliance.- Review and Approve general release documentation for GCP Products.- Support CAPA activities including reviewing objective evidence to support CAPA closure.- Perform internal audits of Key Process Areas relevant to GCP.

Columbus, Ohio Area

- Supported CTMS data migration project - Led issue resolution tasks on team status calls- Reported system defects while the product was still in development

Souderton, Pa

- Lead 50 client audits a year.- Consult with key stakeholders to provide completed audit responses- Initiate CAPAs to fulfill audit findings.- Manage process improvement initiatives to gain greater business efficiency- Authored SOPs

- Lead company through MHRA GCP Inspection - Lead 50 client audits a year. - Consult with key stakeholders to provide completed audit responses - Initiate CAPAs to fulfill audit findings. - Manage process improvement initiatives to gain greater business efficiency - Oversee the yearly Disaster Recovery drill

Souderton, Pa

- Participate in roughly 50 Client and Internal Audits a year.- Consult with key stakeholders to provide completed audit responses- Initiate CAPAs to fulfill audit findings.- Lead process improvement initiatives to gain greater business efficiency- Oversee the yearly Disaster Recovery drill

Souderton, Pa

- Provided Tier 2 Customer Support for clinical study sites participating in clinical trials utilizing IXRS technology.- Worked in a team environment to manage drug inventory through daily drug ordering- Mentored newer colleagues and provided onboarding training- Consulted with client users on the proper expectation and execution of IXRS technology

Souderton, Pa

- Provided Tier 1 Customer Support for clinical study sites participating in clinical trials utilizing IXRS technology.- Managed access credentials being sent out to clinical study sites- Worked on a team to maintain system access of roughly 150 users for a key client.