# Senior Clinical Data Manager

**Company**: Fortrea
**Location**: Mexico City
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Mexico-City/Senior-Clinical-Data-Manager_264632?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_f6993bc5-297

## Description

We are seeking a Senior Clinical Data Manager to lead studies and provide data management leadership on studies. You will be responsible for the development of project documentation, system set-up, data entry and data validation procedures and processes. You will act as a subject matter expert (SME) for DM activities in relationship meetings with Sponsors and work directly with Sponsors to understand their direct requirements.

**Responsibilities:**

- Lead studies including healthy volunteer and patient populations, multi-site, complex protocol design, and strong client management

- Be accountable for all DM deliverables as assigned per the established timeline

- Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs

- Work with the Project Manager(s) or FSP Lead (or designee) to build timelines to meet contracted milestones

- Provide DM project team leadership and accountability

- Maintain awareness of other Biometrics functional group deliverables to support risk and mitigation strategies

- Keep Project Manager (or designee), Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information

- Coordinates the receipt and inventory of all data related information

- Develop and maintain client relationships and review client satisfaction surveys

- Track scope changes and work with the Project Manager or FSP Lead (or designee) to ensure that Sponsor approval is received

- Provides leadership, mentorship, and coaching in DM related clinical trial processes

- Accountable for learning new DM technologies and applied processes

- Ensures service and quality meet agreed upon specifications per the DMP and scope of work

- Have input in writing, reviewing, and updating SOPs and associated documents as required

- Maintain accurate records of all work undertaken

- Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate

- Represent DM and where necessary overall Biometrics in new business opportunities

- Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe

- Works with management team to develop and implement directional strategy by providing technical input into discussions

- Actively promote Biometrics services to sponsors whenever possible

- Performs other related duties as assigned by management

**Qualifications:**

- University / college degree

- 8 years of combined early or late-stage DM experience with minimum 2 years of direct sponsor management and at least 2 years technical mentoring experience

- Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations

- Proven ability to lead by example on project strategies and achievement of department goals, objectives, and initiatives

- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies

- Time management skill and ability to adhere to project productivity metrics and timelines

- Ability to work in a team environment and collaborate with peers

- Ability to mentor junior members of the department, providing SME guidance on DM practices

- Experience of representing DM in bid defense meetings, providing innovative solutions to meet client needs

- Good organizational ability, communication, and interpersonal skills

- Constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events

**Preferred Qualifications:**

- University / college degree (life sciences, health sciences, information technology or related subjects preferred)

- Through knowledge of Fortrea, the overall structure of the organization and Standard Operating Procedures (SOPs)

- Four or more years of Electronic Data Capture experience

**Physical Demands/Work Environment:**

- Role is office or remote-based, with associated risks of repetitive strain injury (associated with keyboard operation) and eye strain (associated with VDU screen operation)

- Potential travel for cross-site support or training needs, meetings up to 10% of the time, with up to 50% of that time requiring an overnight stay

## Skills

### Required
- clinical trial management
- data management
- leadership
- project management
- regulatory compliance

### Nice to have
- Electronic Data Capture
- life sciences
- health sciences
- information technology

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Mexico-City/Senior-Clinical-Data-Manager_264632?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)