Early Development Lead Clinical Data Manager

2 months ago

Hackensack, New Jersey, United States Parexel Full time

Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end-to-end data management activities pertaining to clinical trials, including but not limited to data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

The LCDM works with management to maintain the consistent execution of quality global procedures and monitors workload and resource allocation, if applicable. Supports the comprehensive development of junior staff and encourages effective interaction with business partners to achieve common objectives. Accountable for the quality and timely execution and deliverables at the trial level.

Primary activities include, but are not limited to:

All responsibilities of a Senior Clinical Data Manager (SCDM)Accountable for all protocol level start-up, in-life and database lock tasks, and activitiesInteract and communicate with customers and stakeholders, both internal and external to teams when neededResponsible to design, create, validate, review, approve, and maintain data management tool specifications, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines; Edit Checks, Data Review Plans (DRPs), and In-life Reports, Encoding and Data Management Plans (DMPs)Coordinate and/or participate in the execution of user acceptance testing of data management toolsProvide input into the preparation of the investigator meetings materials and makes him/herself available for questions. May present data management instructions at investigator meetings based on business need and management decisionsParticipate in relevant operational meetings to identify and incorporate global operational issues into the study designExecute and trigger communications and escalations at the protocol level within the department, within function and cross-functionallyExecute and maintain adherence to a metrics control plan and quality assessment indicators at the trial levelCoordinate the database lock preparation and monitoring of checks, such as data flow and deviations monitoring, for data repository and triage issues according to report outputAccept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/or other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes, leading or participating in cross functional technical improvement projects, etc.Continually monitor for opportunities to improve efficiency, effectiveness, and quality, and implement changes as appropriate at the trial level, program level, TA level and department levelPerform tasks with minimal guidance from manager(s)Support and execute any role or task in the team when neededMinimum FTE Years of ExperienceApproximately 3 years or more of experience in data management, medical research, or database design and development is preferableExtensive start-up and in-life data management experience is requiredKnowledge of database structures and available tools to manage, extract, and report data, is preferredFluent oral and written English language skillsKnowledge of applicable regulations and policiesProficient overall working knowledge of the clinical development processGood working knowledge of clinical practice and medical terminologyAbility to work cross-functionally and as part of a teamBe able to work under pressure in a changing environment with flexibilityAbility to work independently and act with appropriate accountability with minimal guidance by a managerAbility to coordinate the work of others and influence decision-makingExceptional communication skills (oral and written), with the ability to communicate with both the technical and business areasExceptional organizational, problem-solving, and negotiating skillsDemonstrated excellent project management and leadership skillsEducational RequirementsAt least a B.A. or B.S. degree, preferably in life science, computer science, or health care related discipline.

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