<p>Job Responsibilities</p> <ul> <li>Manage the scope of work, objectives, timelines, quality of deliverables, and all other activities of the business unit </li><li>Oversee data transfer process lifecycle; including template set-up, test data generation and execution, addressing QA audits, and submission of data to clients </li><li>Oversee the execution and provide support for study data transfer activities, database set-up, sample reconciliation, data compilation, and data formatting </li><li>Ensure delivery of high-quality scientific reports that meet industry standards </li><li>Manage performance and professional development of staff </li><li>Provide guidance and decision-making on scientific, operational, and regulatory issues, as appropriate </li><li>Present improvement strategies to clients and/or Management </li><li>Establish group/team objectives </li><li>Oversee resource and capacity planning </li><li>Work alongside senior colleagues to define strategies for business success and growth </li><li>Establish Key Performance Indicators to identify opportunities for improvement </li><li>Participate in client and regulatory audits as required </li><li>Implement programs and drive process improvement </li><li>Oversee staff recruitment, training, and progression </li><li>Ensure employee adherence to regulatory compliance for data integrity and assigned SOPs · Review and author SOPs, as appropriate </li><li>Other tasks as assigned </li><li>Education, Skills and Qualifications </li><li>BA/BS or higher with 10+ years management experience; all experiences will be evaluated </li><li>Strong knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP </li><li>Able to mentor and develop staff </li><li>Able to work in a regulated environment </li><li>Able to work effectively and contribute within a team </li><li>Able to work with computer systems </li><li>Able to document clearly </li><li>Able to communicate clearly </li><li>Experience in a regulatory environment </li></ul>