Manager Data Management

Life Sciences WA; Charleston, Northern (SC, KY); Hybrid; USD 125,000 - 170,000; Full time

Job summary

Novotech is seeking a Manager Data Management to lead a Data Management team, ensuring that trials comply with GCP, regulatory requirements, SOPs, and project agreements. The role includes recruitment, resource planning, performance reviews, and maintaining high-quality deliverables.

Candidates should have a degree in clinical/biological/mathematical sciences with at least 6 years in data management, and hands-on experience with Medidata Rave, Veeva or Viedoc, plus exposure to RTSM/IWRS and

Qualifications

• 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.
• Exposure to RTSM/IWRS and eCOA/ePRO preferred
• Experience in Spotfire, POWERBI, JReview, Clinical Data Studio is an added advantage.
• End-to-End Data Management Experience
• Demonstrated experience in: 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.
• Successfully led 10 or more clinical studies as the Lead Data Manager; oncology studies mandatory.
• Direct experience engaging with sponsors/customers throughout study startup, conduct, and closeout phases.
• Strong verbal and written communication skills with ability to engage and influence stakeholders.

Responsibilities

• Manage a team of professional Data Management staff.
• Define and prioritize resource requirements and manage resource assignments across projects.
• Active recruitment of new staff.
• Review and prioritise resourcing allocation across projects.
• On-boarding, training and integration of new line reports.
• Manage workload, welfare and developmental needs of team members.
• Performance management including goals, competency assessments, and salary reviews.
• Approve leave requests and timesheets.
• Provide expert review and guidance for Data Management deliverables.
• Offer technical advice to improve efficiency.
• Develop and implement new processes and technology; oversee project-specific applications.
• Understand scope, budget and milestones; ensure timelines and quality.
• Support in proposals and change orders; collaborate with management, PM and business development.
• Ensure high-quality deliverables at site-level via senior review and sponsor audits.
• Maintain site-level utilisation and project profitability.
• Act as backup for line manager.

Skills

Data Management

Team leadership

Clinical trials

Medidata Rave

Veeva

Viedoc

RTSM/IWRS

eCOA/ePRO

Spotfire

POWERBI

JReview

Clinical Data Studio

Education

Clinical/biological sciences degree

Tools

Medidata Rave

Veeva

Viedoc

RTSM/IWRS

Job description

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.

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.

Biometrics Support Management

• 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.

Minimum Qualifications & Experience:

• 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.
  • Exposure to associated modules such as RTSM/IWRS and eCOA/ePRO preferred
  • Experience in Spotfire, POWERBI, JReview, Clinical Data Studio is an added advantage.
• End-to-End Data Management Experience
  • Demonstrated experience in:
    • 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
• Successfully led 10 or more clinical studies as the Lead Data Manager. Experience leading three or more oncology studies is mandatory.
• 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

The salary range for this position is $125,000 - 170,000 based upon experience.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.