Qualifications BS in Life Sciences discipline Must have 10 years of relevant experience Experience with high enrolling large scale trials in TAs such as vaccine, cardio, diabetes, etc. Experience with managing clinical quality activities and in-depth knowledge of clinical operations. Experience with clinical trial site/process audits and regulatory inspections Experience in line management of employees Experience translating Pharma/Sponsor needs for innovation and creative approaches to quality management Senior Manager-Patient Recruitment Clinical Trials Responsible to develop a new set of patient recruitment and retention services to allow the study teams to plan, forecast, and achieve patient enrollment goals. This includes but is not limited to being the subject matter expert for the RWE proposal teams, develop patient recruitment and campaign strategies operations that will leverage the client’s assets and digital and tech enabled solutions. This role will be responsible to develop and engage clients for capabilities presentations and solution development through all phases of campaign execution. Ensure Standard Operating Procedures (SOPs) and Internal Operating Procedures are reviewed periodically and advise on required updates to ensure compliance with ethical, regulatory and other relevant frameworks, making recommendations for improvement where appropriate Identify to ensure all clinical trials staff are trained on SOPs Ensure staff SOP training requirements are achieved for QA and Implement and maintain a Quality Management System (QMS) in line with the Corporate QMS and take the lead in presenting it to internal stakeholders, pharmaceutical companies and other funding partners Build, manage, lead and motivate a QA team, ensuring that people with the right range of skills and experience are recruited and retained, and that their skills and professional capabilities are maximized Ensure quality and operational compliance; act as a subject matter expert for quality investigations, documentation systems, training programs, internal/external audits, and vendor assurance programs Develop and implement a risk-based and flexible approach to QA in compliance with applicable regulatory requirements Generate and analyze weekly, monthly and quarterly metrics to track KPIs Work with Operations team to implement, review and maintain tracking of incidents within the clinical trials, advising on CAPAs to be implemented and ensure completion in a timely manner Lead the Audit Program management process, including assessment of internal and external (outsourced) operations, and active audit and regulatory inspections Partner with functional areas in study design, data collection, and analysis, and reporting activities that support quality improvement interventions, transparency, compliance with regulatory standards, and provide performance monitoring About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.