Woodcliff Lake, NJ
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 Data Manager. The Data Manager is located in Woodcliff Lake, New Jersey and will manage end-to-end delivery of data management services for assigned projects, and will collaborate with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.
- Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies with less complexity
- Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies with less complexity
- Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting)
- Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines
- Ensures Data Management deliverables meet project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed and archived according to applicable regulatory requirements
- Minimum of 5+ years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO)
- Experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic areas
- Experience in continuous improvement, project management, change management, and risk management
- Working knowledge of Electronic Data Capture and related applications, plus industry standards
- Technical Data skills in working with data received from CROs and other third party vendors
- Knowledge of clinical operations and relevant regulatory requirements
- MS/BS/RN in life sciences or related field (or equivalent experience)
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.