Lead Clinical Data Manager (LCDM)

Job Description

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 integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with company Standard Operating Procedures (SOPs) and ICH-GCP guidelines. Works with management to maintain the consistent execution of quality global procedures. If applicable, monitors workload and resource allocation. Supports the comprehensive development of junior staff and encourages effective interaction with business partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of deliverables at the trial level.

Primary activities include, but are not limited to:

• All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager (CDM).

• Responsible for all protocol level start-up, in-life and database lock tasks and activities.

• Interact and communicate with customers and stakeholders both internal and external to GDMS as well as our company when needed.

• Responsible 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 &/or participate in the execution of user acceptance testing of data management tools.

• Provide inputs into the preparation of the investigator meetings materials and makes him/her available for questions. May present data management instruction at investigator meetings based on business need and management decision.

• Participate in relevant operational meetings to identify and incorporate global operational issues into the study design.

• Execute and trigger communications and escalations at the protocol level within department, within function and cross-functionally.

• Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial level.

• Coordinate the database lock preparation and monitoring of checks, such as data flow and derivations monitoring, for clinical data repository and triage issues according to report output.

• Accept 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 level.

• Performs tasks with minimal guidance from manager(s).

• Support and execute any role or task in the team when needed.

• Primary responsibility in training new staff (CDMs, SCDMs and new LCDMs).

Education/Experience (Ex-US , subject to local requirements):

• At least B.A. or B.S. degree, preferably in life science, computer science, or health care related discipline with at least 3 years’ professional experience in clinical data management;

• OR

• Associates Degree with at least 5 years’ professional experience in clinical data management;

• OR

• High School Diploma (or equivalent) with at least 8 years’ professional experience in clinical data management.

Knowledge and Skills:

• Knowledge of database structures and available tools to manage, extract, and report data is preferred

• Fluent Oral and written English language skills

• Knowledge of applicable regulations and policies

• Proficient overall working knowledge of the clinical development process

• Good working knowledge of clinical practice and medical terminology

• Ability to work cross functionally and as part of a team

• Be able to work under pressure in a changing environment with flexibility

• Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager

• Ability to coordinate the work of others and influence decision making

• Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas

• Exceptional organizational, problem-solving and negotiating skills

• Demonstrated excellent project management and leadership skills

• Proficient in Microsoft Office, especially MS Excel

#ONEGDMS

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday – plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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Expected salary range:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R252026