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.
PXL is seeking an operations lead with expertise in lab operations and proficiency in computational programming to support the generation and delivery of quality biomarker samples and data.
Job Responsibilities:
- Establish and streamline SKDL processes to increase efficiency and implement analytical tools to advance departmental goals.
- Support SKDL operations, including samples, kits, and data processes, ensuring integrity and completeness for database locks.
- Use technical tools/systems and programming languages to systematically clean data, including processing confidential data according to guidelines.
- Programmatically aggregate and extract key information from operational reports
- Possess knowledge of structured data, such as entities, classes, hierarchies, relationships, and metadata, with the ability to perform data mapping
- Support processing of informed consent forms (ICFs) and ensure compliance with ICFs for internal sample handling, tracking, usage, and destruction.
- Maintain and review metrics related to clinical study samples, data, kits, and logistics.
- Lead cross-functional study teams, manage vendor relationships, and oversee clinical trial biosamples and data monitoring.
- Support clinical trial biosamples and data monitoring and completeness from collection through to disposal, per requirements of the study
- Anticipate challenges, manage dependencies, and mitigate risks across SKDL projects.
- Enhance communication with senior stakeholders and align SKDL functions with group objectives.
- Participate in vendor oversight activities, including issue escalation, metrics reviews, and performance monitoring
Job Requirements:
- Proficiency in one or more programming languages (R, Python, Perl, SQL, MATLAB)
- Familiarity with APIs, database development, dashboard development, and Linux/Unix environments
- Ability to critically analyze and plan for sample interdependencies, risks, and issues with an awareness of the impacts to clinical studies/program.
- Strong problem-solving, project management, and organizational skills, with ability to effectively multi-task and prioritize.
- Extensive process development and project management experience including vendor management
- Excellent oral and written communication and presentation skills
- Advanced excel knowledge required
- 6-7 years of experience in lab operations and programming preferred.
Education:
- Bachelor’s or master’s degree.
Experience:
- 6+ years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings, with knowledge of clinical trials and clinical databases.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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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.
