Data Management leadership on studies considered to be high complexity. 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. Also assume responsibility for all data management activities leading to database lock according to client quality expectations, within project timelines and budgets.
Act as subject matter expert for Data Management activities in relationship meetings with Sponsors. Work directly with Sponsors to understand their direct requirements and lead implementation of those requirements. Regularly review client specific process to ensure they remain optimal for Sponsor and Covance.
The Clinical Data Manager III will work with the senior leadership team to provide guidance, mentoring and training to Data Management to ensure best working practices are maintained.
* Lead study Data Manager for studies which are highly complex including but not limited to - combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines.
* As the study data lead/Client programme lead; be accountable for all 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 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 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. budget status, 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.
* 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.
* Coordinates with the DM Global Trainer and DM technology SMEs to coach and mentor study members on DM technologies and best practices for DM applications/tasks such as (EDC execution, SOP forms completion, tracking tools, reviewing vendor data in SAS Viewer, data listings creation, data cleaning).
* Provide support to Data Management supervisors and 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 Covance.
* 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.
* Maintain accurate records of all work undertaken.
* 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.
* Represent Data Management and where necessary overall Biometrics in new business opportunities.
* Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
* Works with management team to develop and implement directional strategy by providing technical input into discussions, and rolling out training/mentorship to DM staff as required.
* 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 eight 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.
* Eight years of combined early or late stage DM experience with four years of direct sponsor management and at least 2 years 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.
* Ability to mentor junior members of the department, providing SME guidance on Data Management practices.
* Experience of representing Data Management in bid defence meetings, providing innovative solutions to meet client needs.
* 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.
* Through knowledge of Covance, the overall structure of the organization and Standard Operating Procedures (SOPs).
* Four or more years of Electronic Data Capture experience.