Data Management leadership for all aspects of the data management process to include but not limited to 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.
Develop and maintain a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.
Essential Job Duties:
* Lead study Data Manager for studies considered to be lower complexity either in terms of study design or client management.
* 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 site initiation meetings.
* 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 Clinical Pharmacology Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts).
* Anticipates and identifies operational and logistical challenges; including mitigation plans and risk management plans and reviews them with the Project Manager, Biometrics management, and the sponsor. Executes follow-through of mitigation plans to completion in a timely manner.
* 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.
* Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Project Manager to ensure that Sponsor approval is received and the scope change processed.
* Demonstrates knowledge of DM utilized tools, systems, and processes.
* Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
* Plan Data Management resources for assigned studies with support from line manager
* 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.
* 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.
* Support 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 four 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.
* Four years of combined early or late stage Data Management experience with one year of direct sponsor management and one year technical mentoring experience.
* Proven experience of handling customer negotiations and exposure to managing Scope of Work and budgets.
* 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).
* Two or more years of Electronic Data Capture experience.