Lead Clinical Analyst at QuintilesIMS

Job description

Primary Functions

The Lead Clincal Analyst (LCA) partners with the Clinical Lead (CL) and local country Site Monitors in project execution. The LCA provides contralized support and contributes to site management for a variety of protocals, sites and therapeutic areas. LCA creates study specific operational plans, supports study start-up, manages resources requests, performs ongoing clinical risk assessment through data trending and analystics and proposes potential mitigating actions in a timely fashion, and manages Investigators payments. The LCA liaises with and mentors the Clinical Analyst Support (CAS) on trial.

Roles & Responsibilities

Study Start-Up

Support the CL to develop the Clinical Operations Plan (COP), and study-specific documents, which may include but are not limited to: The Monitoring Plan, SDV Plan, Study Reference Manual/Guidelines/Instructions, annotated Site visit report, annotated Recruitment Strategy Plan (RSP) and Site Recruitment Action Plan (SRAP), letter templates, scripts for remote monitoring visits and telephone contact report templates as applicable. The LCA also develops training material for SSV / SIV.

• Request resources in QRPM that will include the Clinical Trial Assitant (CTA) and Clinical Analyst Support (CAS), Clinical research Associate (CRA), and team members as applicable.
• Manage system access for site management team.
• Maintain all study specific traings and assign to team memberts

Do you need experience or a degree to apply for this position?

• You must have a Bachelor's degree in life sciences or related field; or equivalent combination of education, training and experience.
• At least 2 – 4 years of relevant Clinical Research Associate (CRA) experience
• You will be required to pass screening assessments to determine your proficiency in terms of English language proficiency, analytical ability and other aptitude