Clinical Study Sr/ Manager (Pharmaceutical Trials, Global Study Management)

Clinical Study Sr/ Manager (Pharmaceutical Trials, Global Study Management) Job Description The Sr. Manager, Site Management Operations (ROM) manages the various levels of Manager, Regional Site (RSM) within an assigned region/s while ensuring appropriate staffing; ascertaining that all timelines are met, and upholds quality monitoring standards. Within the study conduct, the ROM functions as a liaison between the RSMs and in‐house clinical team within Drug Development Operations (DDO). The ROM may liaise externally with Investigator site personnel, Vendors, CROs and partner personnel. The administrative tasks of the ROM include RSM time and expenses, which are aligned with work performed, budget, regulations and company policies. The ROM assists in the development, review and implementation of GSMO policies and supports the preparation and conduct of audits and health authority inspections. This role requires approximately 30% ‐ 40% travel. The employee is expected to be fully capable of performing roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. The employee must conduct their work activities in compliance with ICH GCP E6, all relevant laws, directives, regulations, and regulatory guidelines as well as all policies and procedures. Line Management Function Responsible for staffing within the assigned region or program. Evaluate the resourcing needs per study and within regional tasks. Assign monitors to studies and sites. Responsible for ‘Resourceful’ (a resourcing tool). Maintain knowledge of study site assignments and manage the workload of individual monitors. Interview, hire and on‐board qualified RSMs to fulfil resourcing needs. Ensure all department Key Performance Indicators, timelines and deliverables are met. Monitoring visits, including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits (remote and on site), and Close Out Visits. Monitoring Visit Report (MVR) submission. Completion of CTMS related activities. Submission of time and expense reports. Conducts and evaluates RSMs on Field Evaluation Visits. Ensure quality of monitoring activities within the assigned region. Facilitate flow of information and integrate field team into the in‐house clinical study team. Subject Matter Expert (SME) Active in the development and communication of Global Site Management Operations policies. Act as a resource for questions regarding applicable SOPs, policies, Working Instructions and guidelines. Examine opportunities for improvement of procedures and practices. Assist in the development of new policies and/or procedures. Requirements Min Degree, preferably in Science / Life Sciences / Public Health / Health Sciences / Pharmacy / Medicine / Nursing or similar from an accredited university. At least 10 years of working experience within clinical research settings (e.g. clinical research associate, study coordinator, or research administrator) is advantageous but not essential. Knowledge of GCP guidelines and applicable regulations and guidelines of clinical research, or ethical principles relating to human biomedical research. Able to work independently, as well as part of a team. Able to work with a high degree of accuracy and attention to detail. Possess excellent analytical, organisation, communication, and interpersonal skills. If you are interested in the position, please send your most updated resume to leonleong@recruitexpress.com.sg (Attn: Clinical Trails Study Manager - Leon) . Thank You. Leon Leong De Cong R1551708 Recruit Express Pte Ltd (Healthcare & Lifesciences Division) EA License: 99C4599#J-18808-Ljbffr