Clinical Data Manager
We are currently searching for a skilled professional to join a well-known client’s team as Clinical Data Manager in Miami, Florida. The Clinical Data Manager role is responsible for overseeing all Data Management operational activities and internal team members, ensuring compliance with the corporate timeline and scope of work outsourced to the Data Management service providers, and coordinating activities from other third party vendors that provide trial data. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Coordinate vendor and technology (e.g., EDC) evaluation, qualification, and selection
- Participate in RFP development and contract negotiation, as needed
- Manage all Data Management (DM) activities insourced or outsourced to DM Service Providers and/or third party data vendors (e.g. central and/or specialty labs, IVR vendors, etc.) from protocol concept through trial close-out and reporting
- Ensure that all trial deliverables and milestones are met on time and within budget
- Partner with Clinical Operations for all trial activities, and lead all DM functional activities
- Provide operational leadership to the direction, planning, execution, collection, and handling of all clinical data to the highest quality standards while ensuring compliance with industry established standards and reporting requirements
- Review trial data for completion and accuracy
- Assess the overall quality of data and identify key data issues, trends or patterns that may indicate overall trial compliance and/or data quality concerns
- Develop and manage the Data Management Plan (DMP)
- Ensure SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical Data Management Practices internally and with DM vendors via regular process auditing
- Develop SOPs, working practices, DM standards, policies and Clinical Development process improvement supporting Clinical DM activities
- Ensure the receipt, proper filing, security, and archiving of trial related data
- Minimum of seven years of relevant clinical experience in the pharmaceutical, biotech and/or CRO industries
- Experience in Core Data Management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries)
- Experience with various clinical databases (e.g., Medidata Rave, Oracle Clinical, SAS) and key technologies (e.g., EDC, Laboratories, Imaging, IVRS/IWRS)
- Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required
- Knowledge of CDISC standards and regulatory reporting and filing requirements required
- Experience in leading and motivating a team of direct staff
- Proficiency in MS Word, Excel, Outlook, and PowerPoint, Project, SAS programming preferred
- Must be willing to travel as required
- Bachelor’s Degree required in a relevant scientific discipline (or equivalent work experience)
- CCDM Certification preferred
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.