Senior Data Manager
We are currently searching for a skilled professional to join a well-known client’s team as Senior Clinical Data Manager in Princeton, New Jersey. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity
- Act as a first point of contact for all data management deliverables for assigned studies
- Ensure all study set up activities are implemented accurately and within defined timelines
- Review and provide input to all study specific documents
- Provide input to the CRF layout as per protocol requirement
- Provide input into Edit Specifications
- Share responsible with CRO for database review, testing and UAT of edit checks specifications for assigned studies
- Responsible for monitoring study progress and timely locking of database
- Accountable for all data management study deliverables from study initiation to database lock
- Ensure audit readiness of data
- Manage relationships with internal and external customers at both the operations level and with functional peers
- Ensure data management milestones are met according to agreed timelines
- Participate in Study Kick Off meetings and Study Team meetings for the assigned studies
- Manage vendors as needed for assigned studies
- Provide accurate reports on assigned projects on regular basis and when requested
- Effectively communicate relevant project information to management
- Attend client and multi-disciplinary project team meetings needed
- Oversight of database build, data review, eCRF development for assigned studies
- Review of standard validation checks and query language, etc.
- Ensure data is of high integrity, complete and accurate
- Oversee the development/maintenance of the Data Management Plan (DMP), Data Validation
- Plan (DVP), and other data management documentation as required for assigned studies
- Other duties and responsibilities as defined by the Director of Data Management
- A minimum of 4 years of experience in Data Management
- Preferably candidate should have a strong background in Oncology
- Must have an excellent understanding of the conduct clinical trials and clinical trial related systems
- Working knowledge of EDC systems, i.e. Medidata Rave, INFORM
- Able to work effectively in a team environment as well as independently with minimal supervision;
- People management experience, preferred
- Minimum of Bachelor’s Degree in Computer Science, Engineering, Business Administration
- Master’s Degree 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