SKDL Programming Lead

Parexel•Southport, NC

About The Position

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 seeking a clinical operations lead with expertise in clinical sample logistics and proficiency in computational programming to support the generation and delivery of quality biomarker samples and data. Responsibilities will include one or more of the following: development of tools and dashboards for sample/data tracking, review of clinical sample collection, resolving sample/data queries, and support of database lock (DBL) activities. Proficiency in Python, R, MATLAB, and/or SQL programming is required.

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
7+ years of experience in clinical operations preferred.
6+ years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings, with knowledge of clinical trials and clinical databases.

Responsibilities

Establish and streamline SKDL processes to increase efficiency and implement analytical tools to advance departmental goals.
Oversee 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.
Manage sample-related issues with central and specialty labs, acting as the primary point of contact for resolution.
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.
Oversee and manage 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