Senior Clinical Data Manager – FSP

Parexel

. Lead large clinical studies or related series of studies with minimal guidance .

Posted 10/6/2026full-timeRemote • Mexico, ArgentinaSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in Data Management within the pharmaceutical or biotechnology industry, with a strong understanding of regulatory guidelines and the ability to lead clinical studies. Proficient in managing Data Management activities, collaborating with multidisciplinary teams, and providing training on EDC and eCRF processes.

Highest-signal resume keywords

Data Management ExperienceProject Management SkillsRegulatory Guidelines KnowledgeEDC Systems CoordinationOncology or CNS Therapeutic Area Understanding

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Data ManagementClinical Study LeadershipECRF DesignData Edit Check SpecificationsDatabase Lock and Freeze ActivitiesUser Acceptance TestingData Management Plans DevelopmentRegulatory ComplianceStatistical Analysis Plans ReviewSerious Adverse Events Reconciliation

Soft Skills

Attention to DetailMultitasking AbilityWritten and Verbal Communication SkillsTeam CollaborationMentoring and Training

Tools & Technologies

Electronic Data Capture SystemsClinical Trial Management SystemsData Management SoftwareEDC SystemsComputer Applications

Industry Keywords

FDA-Regulated EnvironmentICH/FDA GuidelinesCDISC StandardsGCDMP21 CFR 11MedDRAWHO Drug DictionariesPhase 1-4 Clinical StudiesOncologyCNS Therapeutic Area

About the role

Key responsibilities & impact

Lead large clinical studies or related series of studies with minimal guidance
Represent Data Management on the CTWG for assigned studies
Mentor and train lower-level Data Management staff
Manage and monitor Data Management activities with CROs and vendors
Review protocols for appropriate data capture and eCRF design
Review eCRF data requirements
Collaborate with CRAs, programmers, study managers, and statisticians on eCRFs, annotated eCRFs, and CRF completion guidelines
Lead development of data edit check specifications and data listings
Coordinate design and testing of EDC systems and resolve system issues
Develop or lead development of Data Management Plans
Review and provide feedback on clinical team documents, including monitoring plans, statistical analysis plans, and vendor specifications
Provide EDC and/or eCRF completion guidelines training
Reconcile external header data and Serious Adverse Events against the clinical database
Lead database upgrades and migrations, including User Acceptance Testing
Maintain study workbooks and Data Management files
Perform database lock and freeze activities according to SOPs
Participate in team meetings and contribute to SOPs, work instructions, and process documents
Assist with training new employees and contractors

Requirements

What you’ll need

At least 8 years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
Good project management skills and proven ability to multitask
Understanding of Phase 1-4 clinical studies and ability to perform core Data Management tasks and interact with vendors
Comprehensive understanding of regulatory guidelines and industry standards, including ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, and WHO Drug Dictionaries
Attention to detail and ability to work individually, within a multidisciplinary team, and with external partners and vendors
Strong English language written and verbal communication skills
Experience and understanding of Oncology or CNS therapeutic area and Phase III pivotal studies preferred
Ability to travel to off-site meetings or training seminars as needed
Solid computer system and technical skills, ability to learn multiple computer applications, and experience with Data Management and Electronic Data Capture systems desirable
BA/BS, preferably in the scientific/healthcare field

Benefits

Comp & perks

Full-time employment
Opportunity to contribute to therapies benefiting patients
Training and mentoring opportunities
Participation in a professional, multidisciplinary environment