Lead study Data Manager for studies which are medium complexity including but not limited to - combination of healthy and patient populations, multi-
providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest delivery quality, while adjusting resource allocations accordingly.
Ensure that all 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.
keeps the Project Manager apprised of project progress. Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and / or functional group management as necessary.
Keep Project Manager, Biometrics management team and / or sponsor services informed of pertinent project or sponsor related information (i.
e. work scope changes, timeline impacts). Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables.
Ensure all appropriate documentation and procedures are performed upon project completion. Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study.
Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training.
Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change processed.
Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations.
Ensures service and quality meet agreed upon specifications per the DMP and scope of work Have input in writing, reviewing and updating SOPs and associated documents as required.
Performs QC on all aspects of work performed in DM to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate.
to ensure that internal and client quality standards are achieved. Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate.
Utilise local laboratory systems and batch data load facilities where appropriate. Perform medical and medication coding Oversee the performance of the Data Management Study team to ensure that client satisfaction is achieved through delivery of quality data, on-
time and on-budget. Arrange internal or external meetings as appropriate. Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe.
Address client comments with the study team. Actively promote Biometrics services to sponsors whenever possible. Performs other related duties as assigned by management
Education / Qualifications
University / college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.
g., nursing certification, medical or laboratory technology). Knowledge of drug development process Knowledge of effective clinical data management practices Fluent in English, both written and verbal In lieu of above requirement, approximately six years experience in related field (e.
g. pharmaceutical, laboratory, data analysis)
Six years of combined early or late stage DM experience in DM with two years of direct sponsor management and two years of technical mentoring experience.
Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets. Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions.
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
Time management skill and ability to adhere to project productivity metrics and timelines Ability to work in a team environment and collaborate with peers Good organizational ability, communication and interpersonal skills Team working skills and good collaborator skills Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events.
Knowledge of medical terminology Knowledge of science or a scientific background is preferred. Good oral and written communication skills