Job Title: Manager, Clinical Data Management
Job Overview
We are seeking a highly skilled and experienced Manager of Clinical Data Management to join our dynamic team in a fully remote capacity. This pivotal role is essential in guiding a dedicated team that provides critical data management support to internal project teams, clients, and Clinical Research Organizations (CROs). The ideal candidate will leverage their extensive expertise to ensure the integrity and compliance of data management processes in accordance with industry standards.
Key Responsibilities
- Deliver data management expertise and comprehensive support to project teams, clients, and CROs.
- Plan, execute, and supervise the formulation of specifications for electronic Case Report Forms (eCRFs), edit checks, and electronic data handling.
- Conduct and coordinate regular cross-functional data reviews, identifying issues and ensuring their resolution.
- Participate in the innovation and implementation of cutting-edge technologies to enhance data management processes.
- Ensure strict adherence to quality control procedures within data management operations.
- Author and oversee the revision of Standard Operating Procedures (SOPs) and training guidelines.
- Facilitate and manage meetings among internal study teams, clients, and CROs.
- Proactively manage project timelines, ensuring resource availability to meet deadlines.
- Identify inefficiencies in data management processes and propose effective solutions.
- Assist in the preparation of project proposals and budgets, while also managing ongoing project budgets.
- Direct daily activities of team members, including training, resource allocation, and performance evaluations.
Required Skills
- A minimum of 12 years of data management experience, or a B.S./B.A. in a relevant science or technical field with 8 years of experience, or an MS degree with 6 years of experience.
- At least 4 years of managerial experience in the Pharmaceutical, Biotechnology, or CRO environments.
- Strong supervisory skills with 6 years of experience leading Clinical Data Managers and overseeing team functions.
- Familiarity with programming in SQL or SAS is advantageous, though not mandatory.
- Proficient in various data collection methodologies and Electronic Data Capture (EDC) systems.
- Exceptional oral and written communication skills, conducive to a collaborative and multidisciplinary environment.
- In-depth knowledge of FDA, EMA, ICH guidelines, and Good Clinical Practices (GCP).
Qualifications
- Demonstrated ability to operate with a high degree of proficiency and autonomy in a managerial capacity.
- Proven track record of leadership in clinical data management projects.
- Capability to review and assess study data quality, along with managing relevant metrics.
Career Growth Opportunities
This position offers substantial potential for professional development and advancement within the clinical research field, empowering you to influence data management practices that directly contribute to the success of key projects in the pharmaceutical and biotechnology sectors.
Company Culture And Values
We value integrity, innovation, and collaboration, seeking to foster an inclusive environment where all team members can thrive and contribute to our mission of advancing healthcare through rigorous data management. Join us as we embrace diversity and promote a culture of respect and professional growth.
Networking And Professional Opportunities
By becoming a part of our team, you will have the opportunity to expand your professional network, engage in skill development initiatives, and collaborate with industry leaders, enhancing your career trajectory in clinical data management.
Employment Type: Full-Time