When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel is hiring a Senior Clinical Data Manager in Mexico or Argentina.
The Senior Clinical Data Manager will be responsible for performing Data Management activities that support client’s commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance.
Essential Functions
- Be able to lead a large clinical study or a series of related studies with minimal guidance
- Represents Data Management on the CTWG for assigned studies
- Provide mentoring and training to lower level Data Management staff assigned to his/her studies
- Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
- Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
- Be able to perform a thoroughly detailed review of eCRF data requirements.
- Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
- Lead the development of data edit check specifications and data listings
- Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
- Develop or lead the development of the Data Management Plan for a clinical study.
- Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
- May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
- Perform reconciliation of header data from external data sources against the clinical database
- Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
- Lead database upgrades/migrations including performing User Acceptance Testing
- Be able to maintain study workbooks and data management files
- Perform database lock and freeze activities per company SOPs
- Participate in regular team meetings and provide input when appropriate
- Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents
- Contribute to a professional working environment including the application of client’s Code of Business Conduct and Ethics
- Assist with the training of new employees and/or contractors
Required Knowledge, Skills, and Abilities
- 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
- Has good project management skills and a proven ability to multitask
- Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform most of the core Data Management tasks and interact with vendors.
- Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong English language written and verbal communication skills.
- Experience and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are preferred.
- Able to travel to off-site meetings or training seminars as needed.
- Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable
Required/Preferred Education and Licenses
- BA/BS, preferably in the scientific/healthcare field.
Skills Required
- At least 8 years of clinical data management experience in the pharmaceutical or biotechnology industry, or equivalent FDA-regulated environment experience
- Experience leading clinical studies or related studies
- Knowledge of Phase 1–4 clinical studies and core clinical data management activities
- Strong project management, multitasking, organizational, and attention-to-detail skills
- Comprehensive understanding of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, and WHO Drug Dictionaries
- Strong written and verbal English communication skills
- Ability to work independently, within multidisciplinary teams, and with external partners and vendors
- Solid computer and technical skills, including the ability to learn multiple applications
- Prior experience with data management technologies and Electronic Data Capture systems
- Experience in Oncology or CNS therapeutic areas
- Experience with Phase III pivotal studies
- Bachelor’s degree, preferably in a scientific or healthcare field
- Ability to travel to off-site meetings or training seminars as needed
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
