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Clinical Data Manager III
Allucent. *At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- *At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
- We are looking for Clinical Data Manager III (CDM III) to join our A-team. As CDM III at Allucent, you will 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 meets the quality standards and regulatory requirements for analysis and reporting.
- **In this role your key tasks will include:**
- - Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites)
- - Plan and project the resources required including management of tasks, timelines, risk and quality
- - Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests
- - Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements
- - Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements
- - Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs)
- - Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
- - Create training materials for EDC users and provide project-specific training as required
- - Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
- - Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
- - Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
- - Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance
- - Support and conduct Quality Review checks during study. As lead DM, may organize and lead Quality Review activities
- - Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA)
- - Manage the database maintenance, lock and close-out processes and procedure
- - Participate in conference calls and/or meetings with vendors and sponsors
- - Recognize and solve potential problems and evaluate effectiveness
- - Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date
- - Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned
- - Help to align data management and clinical programming best practices, standards and conventions within the company
- - Propose and support initiatives for improving efficiency.
Requirements
What you’ll need- **To be successful you will possess: **
- - Minimum Educational Requirement: Preferably Life science graduate or equivalent qualification
- - 6+ years’ experience in clinical data management experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries
- - Proven knowledge of clinical data management processes and clinical database systems, including Electronic Data Capture applications.
- - Good communication skills written and verbal.
- - Effective working knowledge of Microsoft Office Suite including Word and Excel.
- - Demonstrated proactiveness, problem-solving, analytical, organizational and time management skills.
- - Demonstrated flexibility and ability to work well in a fast-paced growing organization.
- - Demonstrated ability to work in a global team environment.
- - Demonstrates a basic understanding of Clinical Trials and the flow of data.
- - Demonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and POI SOPs.
- - Comprehension of study documentation standards including Trial Master File organization and archival processes.
- - Familiarization of data standards, preferably CDISC STDM.
Benefits
Comp & perks- **Benefits of working at Allucent include:**
- - 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical data managementdatabase designdata cleaningdata validationElectronic Data CaptureUser Acceptance Testingdata transferdata reconciliationCDISC STDMTrial Master File organization
Soft Skills
communication skillsproblem-solvinganalytical skillsorganizational skillstime managementflexibilityteamworkproactivenessleadershipquality review
Certifications
ICH-GCP compliancePOI SOPs compliance