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Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. Youll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, youll help make a positive difference in patients lives.

Summary:

The Clinical Data Manager II (CDM2) assists in data management related activities of the Allucent Data Management (DM) department.

This position supports and performs DM-related activities 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.

The CDM2 works on studies with minimal supervision from a CDM3 or Senior CDM.

The CDM2 is a member of the Data Management staff.

This role will support U.S. Government contracts awarded to Allucent that specifically require U.S. citizenship or Green Card holders. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Location: United States

Workplace Type: Remote, Hybrid, or on-site

Responsibilities:

• Assist in DM-related tasks and collaborate with Lead DMs and relevant roles within Data Management (e.g. Clinical Programmers, Data Scientists). May act as primary contact for DM with all relevant parties, both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Biostatistics and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites).
• Provide feedback and status updates to Lead DM regarding progress, timelines, risk and quality and plan and when assigned as lead CDM, project resources based on assigned tasks and projects.
• 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.
• Provide support during clinical study database set-up, including eCRF design and database validation requirement and may lead these activities.
• Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan).
• 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.
• Participate in creating data cleaning strategy in consultation with applicable functional groups and assist in 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. May organize and lead Quality Review activities on behalf of lead DM.
• Support and/or manage the database maintenance, lock and close-out processes and procedure.
• May 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.
• Contribute to other areas of business as required.

Requirements

• This role will support U.S. Government contracts awarded to Allucent that specifically require U.S. citizenship or Green Card Holders.
• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

• Life science, healthcare and/or combination of education and experience
• Minimum 2 years of relevant work experience as Clinical Data Manager
• Minimum 2 years of experience in drug development and/or clinical research
• Good knowledge of ICH-GCP, GDPR/HIPPA and applicable (local) regulatory requirements
• Good understanding of Medical Terminology
• Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, familiar with IRT and eCOA
• Active participation and support in Data Management activities related to database setup, data cleaning and query management, external data reconciliation for at least 3 studies.
• Good 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

Skills:

• Strong 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
• Eye for detail, strong technical, analytical and problem-solving skills
• Good project management skills
• Ability to translate guidelines, rules and regulations in clear and usable recommendations
• Ability to simplify complex issues into understandable concepts

Benefits

• Comprehensive benefits package
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for fully remote working or Hybrid Working Model

• Leadership and mentoring opportunities
• Internal growth opportunities and career progression
• More task variety
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms

To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes.

#PO #LI-remote #LI-hybrid #LI-onsite #LI-TCW