Job Details

Join our team as a Clinical Laboratory Study Manager, where you'll work closely with the Precision Medicine Strategy Lead and various clinical study teams, including data management, Samples, Kits, Data, Logistics (SKDL), and Clinical Laboratory Project Management (CLPM) groups. Your efforts will ensure the delivery of high-quality samples and data essential for biomarker and non-biomarker evaluations and facilitate the translation of scientific research into medical practice. You will collaborate with project managers and contribute your expertise to clinical trial management (CTM) and CRO to guarantee sample collection adheres to protocol while resolving related issues or queries. Your role will encompass comprehensive project management aligned with our core business strategy.

Operations Management

Study Team Support

• Support individual clinical study teams on all technical and operational sample-related matters for your assigned projects by coordinating with internal stakeholders. Engage with the Informed Consent Form (ICF) specialist in SKDL to address ICF and other trial documents affecting samples and testing.

Operational Support of Sample Analysis

• Establish, oversee, plan, and integrate all aspects related to the collection, processing, storage, shipping, and transfer of samples and data, including reporting and billing for study-related operations.

• Collaborate with Precision Medicine Strategy Leads and other scientists by assessing vendors, forecasting sample operational costs, setting timelines, and reviewing invoices to ensure budget alignment.

Data Acquisition and Management

• Work closely with the data management lead to determine how sample and testing data will be captured, blinded, and transferred throughout clinical trials.

Human Sample Management Flow and Compliance

• Guide clinical teams and sites regarding the collection, storage, and shipping of samples acquired during clinical trials or other human sample acquisition projects.

• Ensure that sample collection and usage comply with study protocol and applicable ICF by working with scientists and the clinical team.

• Collaborate with the internal Human Sample Management team to ensure all samples transferred to research groups are adequately documented, tracked, utilized, and disposed of securely.

Compliance with Organizational Standards

• Adhere to the required training curriculum.
• Accurately complete timesheets as needed.
• Submit expense reports in a timely manner.
• Update your CV as necessary.
• Maintain effective relationships with other platform lines, Business Units/Research Units, and enabling lines to facilitate successful portfolio delivery.

Skills:

Strong written and verbal communication skills.

Ability to resolve issues spontaneously and possess exceptional project management and organizational skills.

Capable of working independently and proactively while contributing to team initiatives and objectives.

Excellent interpersonal skills, enabling effective collaboration with diverse groups and teams.

Proficiency in Microsoft applications.

Knowledge and Experience:

6 to 8 years of experience in clinical research within academic, CRO, or the pharmaceutical/biotech industries. We seek professionals with a solid understanding of clinical trials and clinical databases. Experience in laboratory sample management is an advantage.

Education:

A Bachelor's degree in life sciences, nursing qualification, or other relevant experience is required.

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.