Clinical Data Manager
At Advanced Clinical, we’re excited to share with you a great opportunity at a growing organization committed to clinical excellence for the position of Clinical Data Manager. The Clinical Data Manager is located in Wilmington, Delaware and is responsible for overseeing all data management activities for assigned projects in accordance with Good Clinical Practices and other relevant procedures and guidelines to ensure that a quality work product is produced and that the timelines and deliverables are met. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange
- Participate in protocol development and review; participate in review of clinical study reports and statistical analysis plans
- Review and provide input to CRF design and CRF Completion Instructions
- Develop test scripts and perform user acceptance testing and validation of the database used to collect the clinical data to ensure that they meet requirements for the entry and reporting of clinical data
- Perform training for appropriate users of the clinical data management system
- Produce ad-hoc or standard listings of data from the clinical data management system using the reporting tools provided
- Contribute to the ongoing development, review and revisions of data management Standard Operating Procedures (SOPs)
- Responsible for line management of a limited number of direct reports
- Manage and collaborate with the Clinical Research Organization (CRO) project team to ensure that study deliverables and timelines are met and to act as the primary point of contact for data management interactions with the CRO
- Participate in the development of proposal specifications, review CRO proposals and budgets, and assist in the selection of CROs for outsourced work
- Monitor the quality of Data Management processes, data, and CRO performance
- Minimum 5 years data management experience required
- Project management experience required
- Experience working with a Clinical Research Organization (CRO) or CRO management experience in data management required
- Experience in direct management of employees within Clinical Data Management preferred
- Oncology, endocrine and/or inflammatory therapeutic area experience preferred
- Bachelor’s Degree required OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT)
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.