About the Role Our client, a globally recognized pharmaceutical organization, is seeking an experienced Senior Pharmaceutical Clinical Trials Manager to join their dynamic team. This position is entirely remote, offering flexibility and the opportunity to manage complex clinical trials from anywhere. You will be responsible for the strategic planning, execution, and oversight of clinical trial activities, ensuring compliance with all relevant regulations and protocols. This includes managing study timelines, budgets, vendor relationships, and cross-functional teams. As a remote leader, you will leverage your expertise to drive successful trial outcomes and contribute to the development of life-changing therapies. Our client is committed to a remote-first approach, providing the necessary infrastructure and support for you to thrive in this role. Your leadership in clinical operations will be instrumental in bringing new medicines to patients faster and more efficiently. This is a significant opportunity to advance your career in clinical research management within a supportive and innovative environment.
Key Responsibilities
- Oversee the planning, execution, and completion of clinical trials according to ICH-GCP and regulatory requirements.
- Develop and manage clinical trial budgets and timelines.
- Select, manage, and monitor Contract Research Organizations (CROs) and other clinical vendors.
- Ensure proper site selection, initiation, monitoring, and close-out activities.
- Develop clinical trial protocols, investigator brochures, and case report forms (CRFs).
- Manage data collection, query resolution, and database lock activities.
- Ensure compliance with safety reporting requirements and SOPs.
- Lead and mentor clinical research associates (CRAs) and other study personnel.
- Liaise with regulatory authorities, ethics committees, and study investigators.
- Contribute to the continuous improvement of clinical trial processes and best practices.
Requirements
- Bachelor's degree in a life science, nursing, or a related field; Advanced degree (Master's, PharmD, PhD) preferred.
- Minimum of 7 years of experience in clinical trial management within the pharmaceutical industry.
- In-depth knowledge of ICH-GCP guidelines and global regulatory requirements for clinical trials.
- Proven experience in managing Phase I, II, III, and/or IV clinical trials.
- Experience with CRO and vendor management.
- Strong project management, organizational, and leadership skills.
- Excellent written and verbal communication skills, with the ability to effectively interact with diverse stakeholders.
- Proficiency in clinical trial management software (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and manage complex projects effectively in a remote setting.
- Strong understanding of drug development processes.
Benefits
- Our client offers a highly competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, a generous 401(k) plan with company match, and paid time off.
- This is a fully remote role, offering maximum flexibility.
- Employees benefit from professional development opportunities, including access to online training, webinars, and support for attending virtual industry conferences.
- You will be part of a collaborative, global team focused on delivering innovative medicines.
- Our client is dedicated to fostering a supportive and inclusive remote work environment that prioritizes work-life balance, ensuring our team members can achieve their best both professionally and personally, regardless of their location near Paarl, Western Cape.