Clinical Data Manager Ii (W2)

The Clinical Data Manager II (CDM II) is responsible for Data Management activities across multiple studies. CDM II will report to the Manager/Sr. Manager, Clinical Data Management and will work closely with a cross-functional team in a fast-paced environment.

The CDM II is responsible for coordinating and supporting data management activities in the design, conduct, data collection and lock of database for clinical trials. As part of the Clinical Team, the CDM II will play a key role in the maintenance of clinical studies and will be expected to interface with internal team, sponsors and external vendors to fulfill many of his/her responsibilities.

RESPONSIBILITIES

This is a direct, hands-on role and the primary responsibility is to perform day-to-day Data Management activities. These responsibilities include, but are not limited to:

· Perform Data Management activities and support to internal and external project teams.

· Perform data cleaning activities including the development, review, and generation of queries and query tracking.

· Create study documentation Data Management Plan (DMP), Data Review Plan (DRP), Data Transfer Agreements (DTA), User Acceptance Testing Plan (UAT), Case Report Form (CRF) Completion Guidelines (CCGs) and other plans as required.

· Organizing and conducting scheduled cross-functional data review, 3rd party data reconciliation, and the identification of data issues and tracking through to resolution.

· Conduct database build activities in addition to database validation and review.

· Create required UAT documentation and execute User Acceptance Testing of assigned clinical databases.

· Participate in the design of Electronic Case Report Forms (eCRF)/ CRF, development of Edit Check Specifications, CCGs, and electronic Data Handling Conventions.

· Work with external vendors (such as safety laboratories, cardiac laboratories, Interactive Response Technology (IRT) and/or electrocardiogram(ECG) system providers, ePRO/electronic diary providers) to develop data transfer documents and perform data reconciliation between the 3rd party data and the clinical database.

· Create and deliver Data Management study metrics, in addition to actively reviewing and providing feedback on study data quality.

· Have a thorough understanding of the study billing guide and be able to complete the follow tasks:

o Forecast hours available against study activities.

o Assess if the study activities are in scope per the approved budget report any out-of-scope changes to the Sr. CDM.

· Enter and verify the time spent on project and non-project work on InClin’s time tracking tool regularly (daily time entries preferred, weekly at the minimum required).

KNOWLEDGE & SKILL REQUIREMENTS

· 8+ years of progressive Data Management experience. B.S./B.A. in a science or a technical discipline degree is preferred, but not required.

· Previous CRO experience is strongly recommended.

· Proficient in MS Excel.

· Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes. Medidata Rave EDC, Medrio eClinical and Clario EDC experience are preferred, but not required.

· Client facing experience is preferred, but not required.

· Ability to identify issues and propose solutions.

· Excellent oral and written communication skills.

· Ability to work in a collaborative and multi-disciplinary environment.

· Attention to detail, ability to prioritize and manage multiple projects with competing and aggressive timelines.

· Availability to travel for clinical, and/or face to face study team meetings in addition to Investigator Meetings if needed.

· Good knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonization (ICH) guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.