Trial Transparency Specialist

Contract duration: 1 year with possible extension

Location: India

Kelly FSP is looking for a Trial Transparency Specialist on behalf of one of our top pharma clients

This role will support the client’s clinical trial transparency processes incompliance with trial transparency laws and requirements and client policies

Description of Role & Responsibilities:

Attend and assist with CDD&T-related meetings

Track the delivery of CSRs to ensure required documents are available for all studies qualifying for disclosure

Liaise with appropriate Clinical Contact for document delivery

Daily maintenance of manual Registry Tracking

Identify protocol-level changes in registered studies and make necessary updates to registry records in PharmaCM

Route registry records for Clinical approval via PharmaCM as required

Liaise with appropriate study team contact to resolve queries on study-level information in the CTMS

Participate in UAT testing, document/data management/cleanup projects, audit preparation and participation when applicable

May assist in the management of requests for studyand patient-level data

Assures management is informed of any problems or unresolved issues that could affect the timely completion of the work or the work quality

Requirements:

College degree required

Proficient in computer applications and the use of databases

Minimum 3-5 years of experience working in a clinical setting

Excellent communication skills, both oral and written are mandatory

International study experience a plus

Demonstrated ability to be customer-oriented in order to achieve high customer satisfaction levels

Demonstrated ability to prioritize and manage multiple tasks

Ability to attend to detail, think logically and to critically evaluate and solve problems

Demonstrated good judgment and independent decision-making abilities, as well as strong follow-up skills