Position - Temp - Precision Medicine Operations
Pay Range - $57.77/hr - $74.55/hr
Location - Remote (US)
Duration - 9 Months

Precision Medicine 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 for the oncology portfolio, specifically the LAG3 program. 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 for the LAG3 program. Proficiency in Python, R, MATLAB, and/or SQL programming is required.

A typical day might include the following:

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

This role may be for you if:

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.

To be considered for this role, you must have Bachelor’s and 6+ years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings, with knowledge of clinical trials and clinical databases.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third-party solicitation