Index Ventures

Position Purpose

This position is responsible for the planning, delivery and execution of the Good Clinical Practice (GCP) QA program on assigned projects/products and global GCP audit activities. The role is responsible for GCP oversight, and for assuring the compliance of clinical trial projects to ARIAD Standard Operating Procedures (SOPs) & Policies, and applicable worldwide regulations and guidelines (e.g. US FDA, EMEA, ICH, and country-specific regulations). Significant opportunity for growth.

This position will report to the Sr. Manager, GCP Audits & Compliance and will require 25-50% travel for conducting audits, including international travel. Candidate must possess excellent oral & written communication and interpersonal skills, as well as computer proficiency; with a demonstrated ability to work independently.

Duties:

Assist in developing SOPs for the management and oversight of GCP activities.
Develop written QA plans for assigned projects/products.
Assess compliance of clinical investigator sites, vendors, and ARIAD programs to FDA, ICH, and other government agency regulations/ guidelines.
Conduct GCP audits of clinical studies at Clinical Investigator sites
Conduct audits of regulatory documents, sponsor processes/procedures, clinical trial databases and vendor/services providers (CROs,.Clinical Labs etc ).
Report results to project team personnel and management, and interact with various teams to ensure corrective actions are taken and to bring audit observations to closure.
Participate in special assignments on various projects (including inspection readiness) as determined by QA management.

Key Skills and Attributes:

Job Requirements:

Training & Education Preferred:

Bachelor’s degree is required.
Equivalent relevant professional experience may be considered.
A medical related degrees is a strong plus
Preferred Prior Experience:

Three to five (3-5) years experience in drug development, clinical research, regulatory compliance, and clinical study monitoring or equivalent.
Minimum of two (2) years previous clinical Quality Assurance (GCP) experience independently conducting a broad range of audits including investigator sites, vendors, processes, databases and regulatory submission documents.
Competencies:

Knowledge of the drug development process, GCP/ICH guidelines is essential.
Understanding of or experience in Pharmacovigilance is a plus.
Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a balanced business perspective

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