Manager Data Management

Novotech Global•Charleston, SC

4d•$125,000 - $170,000

About The Position

The Manager Data Management will have responsibility for Data Management staff as assigned and ensures that line reports conduct clinical trials according to all applicable Good Clinical Practice (GCP), Regulatory Requirements, Standard Operating Procedures (SOPs) and the Project Agreement.

Requirements

A degree in clinical, biological or mathematical sciences or related field, with a minimum of 6 years of relevant work experience.
Advanced knowledge of Data Management processes and systems.
Hands-on experience with Medidata Rave, Veeva or Viedoc.
End-To-End Data Management Experience
Developing Data Management Plans (DMPs)
Creating Edit Check Specifications
Database validation and testing
Ongoing data cleaning activities
Laboratory data reconciliation
SAE reconciliation
Spot checks and quality reviews
Database lock and closeout activities
Study Leadership Experience
Successfully led 10 or more clinical studies as the Lead Data Manager.
Direct experience engaging with sponsors/customers throughout study startup, conduct, and closeout phases.
Strong verbal and written communication skills with the ability to effectively engage and influence both internal and external stakeholders

Nice To Haves

Exposure to associated modules such as RTSM/IWRS and eCOA/ePRO preferred
Experience in Spotfire, POWERBI, JReview, Clinical Data Studio is an added advantage.
Experience leading three or more oncology studies is mandatory.

Responsibilities

Manage a team of professional Data Management staff (after 12 months).
Define and prioritize resource requirements and manage resource assignments across projects.
Actively contribute to recruitment of new staff.
Review and prioritise designated resourcing allocation, not only direct line reports, on projects, liaising with Line Manager and Biometrics staff as required.
Ensure on-boarding, training and integration of all new line reports and that process is completed as per company policy. Ensure that they understand the company policies and procedures appropriate to their position.
Meet regularly with line reports. Review and manage their workload, welfare and developmental needs.
Performance management of line reports; set and agree written goals and objectives, competency assessments, coordinate salary reviews and promotions and maintain succession plans.
Review and approve leave requests, timesheets etc. in line with company policies.
Provide expert review and guidance for production of Data Management deliverables to internal and external customers.
Provide technical advice and solutions to internal and external customers to solve problems and improve efficiency.
Participate in the development and implementation of new processes and technology. This may also include oversight in the development of project specific applications ensuring company documentation and system validation requirements are adhered to.
Understand scope of work, budget, and scope assumptions.
Ensure project milestones are met according to agreed timelines and actively manage quality throughout projects.
Provide support in creation and review of proposals and change orders for the Biometrics Department. This will relate to Data Management, Clinical Programming and Biostatistical activities and will require working with management, project management and business development to gain approval.
Ensures high quality deliverables at site-level by providing senior review of core deliveries for accuracy, performing in-progress audits and attending sponsor audits.
Maintains departmental site-level utilisation/realisation and project-level targets at a profitable level.
Act as backup for line manager or line reports if required.
Support the delivery of consistent training and development of line reports in order to develop growth and promotion from within the Data Management group.
In collaboration with Novotech Management, the Data Management group and other Novotech Departments, identify and implement opportunities for better support of cross functional teams.
Represent Novotech at bid defence meetings.