Jobgether
Serve as the primary contact for clinical trial sites to ensure protocol adherence and high-quality study execution from initiation to close-out. Conduct site visits and remote monitoring to maintain data integrity and ensure compliance with regulatory guidelines.
Requires a degree in biological sciences, pharmacy, nursing, or a related health discipline along with solid experience in site management. Must be proficient in clinical systems like CTMS and EDC and be willing to travel extensively.
Serve as the primary point of contact for assigned clinical trial sites, ensuring protocol adherence, operational compliance, and high-quality study execution from initiation through close-out. Conduct site visits (qualification, initiation, monitoring, and close-out) as well as remote contacts to evaluate site performance, resolve issues, and support ongoing study activities. Build and maintain strong relationships with investigators and site staff while providing training, guidance, and ongoing support to ensure regulatory and procedural compliance. Monitor and ensure data integrity by reviewing CRFs, resolving queries, tracking SAEs, and addressing any data quality concerns in collaboration with site teams. Oversee site documentation, including regulatory files and TMF contributions, ensuring audit and inspection readiness at all times. Assess site recruitment strategies, study progress, and performance, recommending corrective actions and improvements where needed. Ensure compliance with ICH-GCP, local regulations, and study-specific procedures while identifying and escalating risks impacting timelines or data quality.
Solid experience in site management or clinical research, with strong understanding of clinical trial methodology, regulatory frameworks, and ICH-GCP guidelines. Degree in biological sciences, pharmacy, nursing, or a related health discipline, or equivalent professional experience. Strong ability to work independently, manage priorities, and make sound decisions in a fast-paced, matrixed environment. Excellent communication, interpersonal, and stakeholder management skills, with the ability to interact effectively with clinical sites and internal teams. Strong analytical, problem-solving, and attention-to-detail skills with a focus on data quality and compliance. Proficiency with clinical systems such as CTMS, EDC, and electronic document management tools, along with MS Office applications. Willingness to travel extensively as required by study demands and site monitoring activities.
Opportunity to contribute directly to global clinical research programs improving patient care and treatment outcomes. Flexible remote-first working model with travel to clinical sites as required. Exposure to international studies and collaboration with global clinical teams and experts. Career development opportunities within a leading clinical research environment. Dynamic, collaborative, and quality-focused work culture with strong emphasis on professional growth. Competitive compensation package aligned with experience and responsibilities.
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