Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons firstname.lastname@example.org
- Working independently, the Senior Clinical Data Manager is responsible for the performance of data management tasks from study start-up through database lock for assigned projects, including paper-based and electronic data capture (EDC) studies, and is responsible for overall data quality and documentation on projects.
- The Senior Clinical Data Manager will work on projects in various indications and will lead a team of Clinical Data Managers to ensure all the contracted activities are carried out according to the Standard Operating Procedures of company and/or Sponsor specific requirements.
- In consort with Data Management leadership, the Senior Clinical Data Manager promotes consistent operations, efficient use of resources, and sharing of knowledge and best practices.
- As directed, s/he will assist with the training of other data managers on project specific and general data management processes, procedures and systems, as well as providing training to other functions across the company as needed.
Primary Duties + Responsibility:
- Lead studies as the Lead Clinical Data Manager; liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues. May also serve as support for other Lead Clinical Data Managers as needed.
- Develop and/or review case report forms (CRFs) within an EDC system and build relevant database structure.
- Develop or quality control review Data Validation Specifications (DVS) documents.
- Program edit checks and other system functions within EDC as needed.
- Facilitate or participate in User Acceptance Testing (UAT) prior to study go-live.
- Author or perform quality control review of data management documents, such as CRF Completion Guidelines (CCGs), Data Management Plans (DMP), and Data Transfer Plans.
- Responsible for data cleaning activities including data review, query generation and management, and development of study metrics either through direct action or delegation to other team members. May find discrepancies, track trends, and identify areas of retraining needed from members of the study team.
- Responsible for the handling and reconciliation activities of external data (e.g., Central Labs, IVRS, etc.).
- Oversee or participate in database lock activities, including managing user access and authoring or providing quality control review of lock documentation
- Partner with other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, Project Management, etc.) to ensure data management aspects of the project are properly considered and integrate well with the other activities.
- Liaise between study center personnel and the client, as appropriate, regarding clinical and/or technical issues
- Perform quality control activities on projects across the department providing feedback to necessary individuals and working with them to correct any issues.
- May serve as a technical lead in a specific area across projects within the department (e.g., Coding Expert).
- Provide mentorship and/or training opportunities for junior level staff within the Data Management department.
- May lead trainings and/or department initiatives to advance teams understanding of these areas and/or improve related processes.
- Serve in a Project Management capacity as deemed necessary and appropriate.
- As requested, assist in business development activities, such as bid defenses and capabilities presentations as the Data Management Team representative.
- Participate in activities related to inspection-readiness, including representing the Data Management group at audits (internal and external).
- Participate in SOPs update and process improvement.
Experience & Minimum Requirements:
- Bachelors degree in a related field & 5 years of relevant experience required; at least 3 years experience in clinical data management in a clinical research setting also required.
- 2 years of experience in leading project teams required.
- Certifications and/or courses completed in Medidata Rave Study Design and Build Essentials strongly preferred.
- Overall understanding of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
- Skilled in use of computer technology, including clinical trial databases and applications (e.g., IBM Clinical Development, Medidata RaveX) and ability to learn new applications
- Detailed understanding of project planning and management methods.
- Demonstrated ability to serve as a strong internal and external consultant, influence without authority, and guide project teams to mutually acceptable outcomes.
- Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.
- Ability to work in different projects with different priorities and act as team mentor, and provide data management expertise.