about the company
Client is a clinical-stage biopharmaceutical company focused on developing novel, oral therapies for rare diseases. The company aims to provide an effective, patient-friendly alternative to injectable treatments, improving the quality of life for individuals with. They are looking for a Regional Clinical Lead to oversee their clinical trial sites in Asia.
about the job
This role involves engaging with study site personnel, including Principal Investigators, Sub-Investigators, study coordinators, and other healthcare professionals, to ensure a clear understanding of the study design, rationale, and eligibility criteria. The individual is responsible for identifying operational challenges at study sites and offering strategic solutions to mitigate these issues. Additionally, they oversee the quality execution of clinical studies, ensuring that any hurdles encountered are addressed and that best practices are applied across multiple sites and studies.
The responsibilities also include participating in study start-up activities such as feasibility assessments, site selection, and document development. The individual performs monitoring oversight of Contract Research Organization (CRO) Clinical Research Associates (CRAs), which includes accompanying them during site visits, reviewing their reports, and providing feedback. They are tasked with building partnerships with CRO CRAs, ensuring that visits are conducted professionally and in accordance with study protocols. They also manage any site or study-related issues, ensuring that corrective actions are implemented when necessary.
In addition, the role supports patient recruitment and retention efforts by ensuring that CROs and clinical sites fully utilize available tactics. The individual is involved in reviewing protocols for operational clarity, facilitating investigator meetings, and collaborating with the study team to establish timelines and milestones. They also work with Medical Affairs to build a Key Opinion Leader (KOL) network and support local events like advisory board meetings. Throughout their activities, they document site interactions, ensuring alignment across study teams and other relevant functions, while also contributing to the development of internal procedures and performance indicators.
skills and experience required
This role requires a BS/BA degree, preferably in life sciences, along with over five years of experience in field monitoring and management within the pharmaceutical industry. The candidate should have a strong background in conducting various types of site visits, including pre-study, initiation, interim, and closeout visits. Additionally, experience in monitoring oversight and site relations is essential, as well as proficiency in using Electronic Data Capture (EDC) systems.
The role demands excellent communication, interpersonal, and organizational skills, along with a deep understanding of current regulatory requirements and guidelines, such as ICH-GCP, that govern clinical research. The ideal candidate should demonstrate strong decision-making and problem-solving abilities, meticulous attention to detail, and the capability to prioritize and manage multiple tasks effectively. Experience or interest in medical affairs topics is also valuable, and good negotiation skills are required.
The candidate should be capable of working both independently and as part of a team, thriving in a fast-paced environment while adhering to established timelines. The role also involves significant travel, with up to 50% travel required. Experience in rare diseases is preferred, indicating a specialized understanding that would be advantageous in this role.
To apply online, please click on the appropriate link. Alternatively, please contact Johari Masod at +65 8282 1340 quoting Ref No. 91M0242743
EA: 94C3609 / R1109554
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