Dedicated Line Manager Sponsor-dedicated

Role and Responsibilities

Clinical Operations Line Manager/ Dedicated Line Manager Role Definition

The DLM is responsible for the direct oversight performance management skills development of Partner employees assigned to Sponsor deployed to a given geographic and/or therapeutic area.

Clinical Operations Line Manager/ Dedicated Line Manager Responsibilities

Recruit interview and identify experienced personnel according to Functional Resourcing Process

timelines.

Ensure and oversee proper onboarding and offboarding of employees compliance to initial and

ongoing trainings.

Attend or facilitate covisits during onboarding period or as needed to assess confidence to perform

activities and site visits alone.

Train and oversee the CORE competencies ICHGCP knowledge clinical research environment

monitoring etc.

Assure adherence to GCP guidelines processes and procedures related to direct reports activities and

performance.

Assure adequate response /escalation and followup on items assigned to direct reports by Sponsor.

Ensure direct reports are providing timely and quality deliverables.

Perform Partner Oversight visits to assess CRA performance according to the clients oversight

plan and inform Sponsor of any quality concerns in a timely manner.

Ensure appropriate and timely reporting of site monitoring activities by CRAs.

Conduct regular 1:1 meetings according to clients oversight plan with direct reports to ensure

deliverables and timelines.

Ensure direct reports are compliant to the timelines and key business metrics defined by Sponsor.

Ensure at least monthly meetings with Sponsor country management to confirm performance of direct

reports regarding protocols / sites assigned.

Communicate and escalate areas of development and training needs.

Conduct continuous Performance review and oversee Personal development and career planning of

direct reports.

Provide timely feedback to Sponsor on performance and ensures proper followup.

Review and approve timesheets expense reports timeoff requests and provide proper oversight of CRAs productivity/utilization

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