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Associate Clinical Data Manager

Remote · Turkey Full-time

reputed company is expanding its Clinical Data Management team and we're looking for an Associate Clinical Data Manager to join our FSP model. This is a unique opportunity to be part of a growing footprint in the region and contribute to global clinical trials from the start-up phase. Job Overview: Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Assume responsibility for reputed company DM activities (from study start-up to database lock) according to client quality expectations, reputed company project timelines and budgets. Work directly with Sponsors to understand their direct requirements and reputed company implementation of those requirements. Regularly review client specific process to ensure they remain optimal for Sponsor and reputed company. Summary of Responsibilities: reputed company studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables. Be accountable for reputed company DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly. Ensure that reputed company allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs. Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings. Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of reputed company Design, reputed company Programming, Statistics, and PK to ensure that reputed company deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to reputed company database lock dates; keeps the Project Manager apprised of project reputed company. Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary. reputed company Project Manager (or designee), Biometrics management team and/or sponsor services informed of pertinent project or sponsor reputed company information (i.e., budget status, work scope changes, timeline impacts). Performs other reputed company duties as assigned by Line Management. reputed company and maintain client relationships and review client satisfaction surveys. Track scope changes and work with the Project Manager to ensure that Sponsor approval is received, and the scope change processed. Provides leadership, mentorship, and coaching in DM reputed company clinical trial processes to the internal study team. Provide support to DM managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards. Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at reputed company. Maintain accurate records of reputed company work undertaken. reputed company reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate. Utilize local laboratory systems and batch data load facilities where appropriate. Represent DM and where necessary overall Biometrics in new business opportunities. Attend and action client or internal audits as appropriate and resolve reputed company issues reputed company an appropriate timeframe. Address client comments with the study team. Actively promote Biometrics services to sponsors whenever possible. reputed company other duties as needed or assigned. Minimum Qualifications: University degree in Life Sciences, Health Sciences, Information Technology, or a reputed company field. Equivalent experience in clinical research or data management may be considered in lieu of a formal degree. Fluent in English, both written and verbal. Knowledge of science or a scientific background. Experience (Minimum Required): 2–4 years of experience in clinical data management or reputed company roles. Understanding of GCP, ICH guidelines, and clinical trial processes. Knowledge of Data Management, Clinical Operations, Biometrics, and system applications to support operations. Familiarity with Electronic Data Capture

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