Leading teams, emphasizing the supervising of staff by creating a positive working environment through the building of solid relationships with team members, the monitoring of workloads of all team members, adjustment and redistribution of assignments accordingly to promote work/life quality, taking into account team members' capabilities and needs and meeting of client expectations, encouragement of team dialogue, providing candid, meaningful feedback in a timely manner, keeping team members and leadership informed on progress and issues.
April 27, 2020
Assist with Data Item Descriptions (DIDs), Contract Data Requirements Lists (CDRLs), data calls, and reviews.
June 04, 2020
Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance to SOPs and relevant Good Regulated Practice (GxP) requirements.
June 17, 2020
Support study-specific regulatory inspection activities at clinical investigator sites by assisting and/or coordinating site inspection preparation activities.
June 29, 2020
Manager of Quality Assurance, GMP in the planning and directing of overall QA activities.
July 13, 2020
Develop and lead with the guidance of their supervisor the execution of audit plans for assigned programs in line with overall QA annual audit plans, including audit resourcing, oversight of consultant auditors, and communications to internal and external stakeholders as applicable.
July 14, 2020
Review change request to ensure the proposed changes are clearly described, justified, and validated or verified as completed per the pre-approved change request.
July 17, 2020