Principal Data Manager

Company Name:
Systems Technology International(STI), Inc
Location :Whippany, NJ
Top Global Pharmaceutical company is expanding in their Whippany, NJ location
They need a Principal Data Manager
(Salary 115-123k, plus bonus and LTIs and more)
MUSTHAVE PREVIOUS EXPERIENCE working within Pharmaceutical, Biotech or Device organization and must have been lead on a project (s)for at least 2 years.
The Principal Data Manager leads the execution of data management activities necessary for the preparation of submission data, and required documentation, for regulatory authorities and the greater clinical research community. S/he is proficient in at least one area related to clinical data management, such that s/he may be considered a subject matter expert on the respective topic. The Principal DM may assume the business role of a Study Data Manager in several studies. In this capacity, s/he serves as the primary contact for Global Data Management on the Core Study Team. The SDM leads the SDM team, which is comprised of several Extended Core Study Team members, to ensure data management deliverables meet, or exceed, corporate and industry quality standards in a timely and cost efficient manner. The Principal DM may also assume the role of a Project Data Manager. In this role, the PDM is a key driver of medical standards implementation and maintenance at the project level. This critical responsibility is necessary to ensure the project data is aligned with the clinical development plan. The PDM ensures consistency across studies through close interaction with the Global Clinical Project Team, mentoring/coaching of SDM and overseeing the Project Data Management team.
DM Expertise
Serves as the key subject matter expert on topics related to data management activities. Contributions include, but are not limited: vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups (e.g., SOPs, OM's, PGDs, etc.), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments.
PDM tasks
Governs use of key data management elements across studies in assigned project: assumes ownership of development and maintenance Medical Standards relevant to the area of responsibility GMS/TAS/CPS/Code lists); provides data structure standards; review application of the Important Medical Event (IME) List, medical coding conventions, and standard coding rules.
Ensures adequate application of Data Management Best Practices across studies within assigned project: review Study Team documents for project consistency; ensure the adequate documentation of all data management activities according to SOPs.
Provides oversight for outsourcing activities by providing input on budgetary items (e.g. RFP, vendor costing, synergies, change orders, etc.), vendor selection and management, risk and communication management, and application of best data management practices.
Advises on resource planning/allocation based on forecasted activities per the Clinical Development
Plan and actual study/project metrics.
Implementing Strategy
Supports the development and implementation of Project and Study Data Management strategic initiatives and activities.Contributes to projects and initiatives aimed at improving and optimizing the delivery of Project and Study Data Management, GDM and GCO services.
Ensuring Compliance
Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.
Ensures complete, accurate and timely documentation for all projects/studies according to established SOPs, Operational Instructions (OIs) and Process Guidance Documents (PGDs)
Tracks and leads project-level data management activities: manage PDM Teams efficiently; ensures the timely delivery of high-quality study databases and smooth operation of SDM teams; identify issues, define and direct resolution measures; reports progress and escalate issues into management.
Represents GDM as the Core Study Team member for internal and outsourced studies, and coordinates the SDM Team in any aspect.
Manages cross-functional team memberships and interfaces effectively: serves as GDM member of the core Global Clinical Team;
Works closely with clinical and safety experts in the definition, preparation and review of reports that are critical to ensuring the quality, accuracy and completeness of analyses on study safety, medical coding and Global Pharmacovigilance data.
Develops robust and productive relationships with internal and external business partners: treats others fairly and with respect; manage conflicts constructively; provide timely and relevant feedback.
Bachelors degree (or equivalent) in natural sciences, informatics or medical documentation
At least 7 years of study and/or project level experience as a Data Manager in supportive and leading roles.
At least 2 years of experience should demonstrate responsibility as the DM lead on studies/project(s).Deep understanding of the drug development process
Strong organizational skills and able to collaborate with minimal supervision.
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