In this role, the selected candidate will be responsible for Data Management leadership for all aspects of the data management process to include responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Also assume responsibility for all data management activities leading to database lock according to Client quality expectations within project timelines and budgets.
Lead data focused project team meetings, meeting frequently with the study leads of Electronic Data Capture (EDC) Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned, coordinated interdepartmentally, and proactively identifying potential risks and mitigations, and effectively communicating data-driven discussions in order to achieve database lock dates with the highest possible data quality.
* Lead study Data Manager for studies which are medium complexity including but not limited to - combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements.
* As the study data lead; be accountable for all DM deliverables per the established timeline; 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.
* Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress.
* Maintain awareness of other Biometrics functional group deliverables to be able to supportrisk 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 PharmacologyProject Manager to ensure that Sponsor approval is received and the scope change processed.
* Provides leadership, mentorship, and coaching in DM related clinical trialprocesses, 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.
* Maintain accurate records of all work undertaken.
* Perform quality control on all aspects of the study as appropriate to include, but not be limited to: all study documentation, query generation and integration; 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.
* 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)
* Knowledge of Covance and the overall structure of the organization
* Knowledge of Covance standard operating procedures
* 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
* Through knowledge of Covance, the overall structure of the organization and Standard Operating Procedures (SOPs).
* Four or more years of Electronic Data Capture experience.
* Experience as a hands on Data Manager with capability of leading and driving all study related deliverables to ensure client expectations are being met in a timely manner and within budget.