Precision for Medicine

Healthcare

SeniorClinicalDataManager

$750–1200k ~AI est. Mexico City, Mexico
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Senior Clinical Data Manager at Precision for Medicine. Skills: Clinical data management, Database management, Data quality, Regulatory compliance. Manage clinical trial data management process. Oversee database development and testing”

What You'll Achieve.

Ensure data management deadlines are met with quality

Industry & Context.

Healthcare
Problems you'll solve

Troubleshoot operational problems; Identify operational issues; Identify study obstacles

Eligibility Requirements

Occasional travel

What They're Looking For.

Must Have

Bachelors and/or related experience, English proficient (Professional level), 8+ years’ experience, Proficiency in Microsoft Office, Excellent organizational skills, Excellent communication skills, Professional use of English (written and oral), Experience in clinical database management systems, Broad knowledge of drug/device/biologic development, Effective data management practices, Representational skills, Leadership skills, Interpersonal skills

Nice to Have

PhD preferred, Experience in clinical/scientific/healthcare discipline, Dictionary medical coding experience, Understanding of CDISC standards, Oncology therapeutic experience, Orphan Drug therapeutic experience

What You'll Do.

Manage clinical trial data management process

Oversee database development and testing

Serve as Primary Data Management contact

Ensure task continuity and responsiveness

Oversee project data entry process

Develop data entry guidelines

Assess and manage timelines

Ensure data management deadlines are met

Assess resource needs for projects

Develop CRF specifications

Coordinate CRF specification review

Assist in building clinical databases

Conduct database build UAT

Maintain database build documentation

Oversee clinical database quality

Specify edit check requirements

Oversee edit check development

Create data management documentation

Revise data management documentation

Maintain data management documentation

Oversee documentation completeness for TMF

Train personnel on CRF and EDC

Review and query clinical trial data

Perform line listing data review

Run patient and study status reporting

Perform medical coding

Coordinate SAE/AE reconciliation

Liaise with third-party vendors

Support vendor timelines and deliverables

Troubleshoot operational problems

Identify study obstacles

Provide feedback on protocols

Provide feedback on SAPs

Provide feedback on CSRs

Participate in SOP development

Participate in SOP maintenance

Attend strategy meetings

Attend bid defense prep meetings

Attend capability presentations

Attend client engagement meetings

Provide project estimates

Provide leadership for initiatives

Train data management team members

Communicate with study sponsors

Communicate with vendors

Communicate with project teams

Present software demonstrations

Present department training sessions

Present company training sessions

Present at project meetings

Perform other duties as assigned

How You'll Work.

Team & Collaboration

Cross-functional teams; Project team members; Study sponsors; Vendors; Project teams

Communication Scope

Verbal communication; Written communication; Representational skills

Process & Methodology

Timeline management, Resource assessment, Project estimates

Full Job Description

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Clinical Data Manager to help build the foundation of our clinical data operations in Mexico. The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines to be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) /program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database May specify requirements for all edit check types e. g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation Oversee completeness of data management documentation for the Trial Master File Train clinical research personnel

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