Clinical Trial Associate

Job Description

OBJECTIVES

Perform daytoday management of CTMS and eTMF including oversight of the review and approval of eTMF documents and generation of reports to measure completeness accuracy and timeliness of the eTMF as per applicable regulations and guidelines and Takeda requirements

Accountabilities

Lead the development of the study specific eTMF plans for assigned clinical studies.

Perform quality control of documents submitted to the eTMF using the established acceptable criteria

Ensure clinical trial documentation is consistent with eTMF specifications ICHGCP guidelines regulatory requirements and applicable SOPs

Address eTMF questions pertaining to how documents are filed and user questions related to the eTMF system

Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations as needed

Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.

Monitor and identify studyspecific eTMF trends and communicate to Clinical Operations and/ or other functional teams as needed

Assist with inspection/audit related activities (e.g. preparation correction action plans)

Maintain up to date knowledge of the TMF Reference Model industry best practices and regulatory requirements

Support Clinical Operations Lead/ Clinical Operations Manager in performing CRO oversight as per agreed parameters

Collaborate with study team leads to lead the setup of studies study teams and sites in the CTMS ensuring programs are configured according to the specific study requirements including countries and sites; grant access for internal and 3rd party vendor users; baseline expected deviation categories study/visit plans visit report letter templates and baseline milestones

Manage enduser and group permission settings.

Lead meetings to escalate trends issues and establish standards based on current industry standards while problem solving and seeking appropriate endorsement across study teams and functions.

Continually assess that CTMS features are functioning properly and efficiently; track all issues observations for future enhancement bug fixes or ongoing needs for training of CTMS features for continuous improvement of the management of the system.

Education Behavioural Competencies And Skills

Minimum Bachelors degree in science/healthcare field required

3 years of relevant clinical research and TMF experience at a biotechnology pharmaceutical company or CRO required

Previous experience working in eTMF system software; experience in Veeva Vault CTMS eTMF system software preferred

Good working knowledge of GCP and local clinical trial rules and regulations

Organizational and problemsolving skills

Superior communication strategic interpersonal and negotiating skills

Proven/ stable performance records over past 23 years

Travel Requirements

Domestic travel may be required (2030%) including some weekend commitments.

Limited international travel (1020%) may be required.

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Remote Work :

No