Remote Principal Project Data Manager

Summary

Join Allucent as a Principal Project Data Manager (PrPDM) and lead data management activities for clinical trials, ensuring quality standards and regulatory requirements are met. As a PrPDM, you will coordinate project timelines, finances, and deliverables, providing leadership and expertise in relevant data management areas.

Requirements

• Life science, healthcare degree and/or combination of education and experience
• Minimum 12 years or relevant work experience in Clinical Data Management or related experience within Biometrics
• Minimum 4 years of experience at Project Data Manager level (or equivalent)
• Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements
• Good understanding of Medical Terminology
• Experience as DM lead on several studies and experience in covering all phases of a clinical study (start up, conduct and database lock). Worked on multiple indications and clinical phases (I-IV)
• Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation
• Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models
• Client management experience
• Experience in developing data management standards
• Excellent written and verbal communication skills including good command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
• Administrative excellence
• Attention to detail, strong technical, analytical and problem-solving skills
• Excellent project management skills
• Ability to translate guidelines, rules and regulations in clear and usable recommendations
• Ability to simplify complex issues into understandable concepts
• Excellent organizational, negotiating, motivational and influential skills

Responsibilities

• Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Biostatistics and if applicable other functional groups, such as Project Management, Clinical Operations) and externally (e.g. sponsors, vendors (EDC, external data), investigational sites)
• Provide expert input in improving processes and deliverables that will support improved client relationships
• Actively monitor for Data Management developments and clinical research related regulations and share this with DM Directors and team members
• Lead internal meetings with internal team members and external meetings with sponsor, and third party (data) vendors, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope
• Manage vendors and vendor relationships as required for project delivery
• Arrange, maintain and circulate project progress and status reports
• Lead the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract
• Ensure overall consistency across all client studies within a set of projects; this especially relates to the DM activities; Data Management Plan (DMP), CRF design, data cleaning and query management) and for Biometrics stand-alone projects also includes statistical deliverables (SAP, TLFs)
• Lead internal meetings with internal project team members. Support and participate in external meetings with sponsor, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope
• Interact, negotiate and influence internal and external team members in a professional manner and with successful outcomes
• Ensure effective and efficient resource utilization across projects and programs
• Manage the study budget, evaluate financial project health and manage monthly status updates for invoicing. Participate in monthly project review meetings
• Proactively recognize and address any changes in scope. Liaise to execute contract amendments
• Oversee Sponsor relationships
• Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA)
• May support operational Data Management activities, also to ensure and assess quality
• Oversee and ensure the Trial Master File for DM services in scope is kept up to date and audit/inspection ready
• Contribute to other areas of business as required
• Research, propose and lead initiatives for improving efficiency

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees