Lead Clinical Data Manager

**Job Description**:

- Position Overview:_
- 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 the 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 _
- _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 in to 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 mínimal guidance from manager(s)._
- _Support and execute any role or task in the team when needed._

**Education**:
At least B.A. or B.S. degree, preferably in life science, computer science, or health care related discipline.

Knowledge and Skills:
1. Previous experience (approximately 3 years or more) in data management, medical research, or database design and development is preferable. Extensive start-up and in-life data management experience is required.

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

3. Fluent Oral and written English language skills.

4. Knowledge of applicable regulations and policies.

5. Proficient overall working knowledge of the clinical development process.

6. Good working knowledge of clinical practice and medical terminology.

7. Ability to work cross functionally and as part of a team.

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

9. Ability to work independently and accept and act with appropriate accountability with mínimal guidance by a manager.

10. Ability to coordinate the work of others and influence decision making.

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

12. Exceptional organizational, problem-solving and negotiating skills.

13. Demonstrated excellent project management and leadership skills.

OneGDMS

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**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R239847