Job Specifications
Lead clinical data. Partner with sponsors. Deliver quality trials.
We are looking for a Project Data Manager (PDM) to join our Data Management A-team at Allucent. As a Project Data Manager, you are responsible for leading and coordinating end-to-end data management activities across clinical trials and biometrics stand-alone projects, ensuring high-quality, compliant, and timely delivery of clinical data.
At Allucent™, we are dedicated to helping small and mid-sized biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
The role
You will lead and oversee data management activities, timelines and finances of the Allucent Data Management (DM) department.
Manage and coordinate DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meet the quality standards and regulatory requirements for analysis and reporting.
You are responsible for the overall coordination and management of Data Management/Biostats standalone projects, large and complex trials and/or multiple projects belonging to one client.
You work closely with sponsors, vendors, and internal teams to ensure data is collected, cleaned, reviewed, and delivered to the highest standards. You combine hands-on clinical data management expertise with strong project leadership, keeping timelines, scope, quality, and budgets on track.
Your main responsibilities will be:
Lead and oversee Data Management activities from database design through to database lock
Act as the primary point of contact for Data Management for sponsors, vendors, and internal stakeholders
Plan, coordinate, and deliver biometrics and clinical data projects according to scope, timelines, and contract
Establish and maintain clear communication, escalation, and risk management plans
Lead internal and external meetings, including Kick-Off Meetings and sponsor discussions
Manage vendors and support vendor selection and oversight where required
Oversee project budgets, financial health, and monthly status reporting
Supervise and support junior Data Management team members, ensuring quality and development
Requirements
You are an experienced clinical data management professional who enjoys taking ownership, working closely with clients, and bringing structure to complex studies.
You will bring the following skills and experience:
Life science, healthcare degree and/or combination of education and experience
Minimum 8 years of relevant work experience in Clinical Data Management or related experience within Biometrics
Minimum 8 years of relevant experience in related clinical trials environment
Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements
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 EDC (Medidata or Veeva) 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
Confidence working directly with sponsors and external vendors
A collaborative mindset and the ability to mentor and guide others
Strong communication skills in English and comfort working in a global environment
Benefits
Comprehensive benefits package per location
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
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
About Allucent
Our mission is to help bring new therapies to light. When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.
If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.
Apply now!
Ready to grow your data management career while contributing to meaningful research to Allucent, apply today o
About the Company
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized pa...
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