Clinical Data Manager Jobs

Overview

We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Data Manager. The Clinical Data Manager role will be responsible for providing laboratory data management support for the clinical trials of the Client’s pharma sponsor customers and consortia.

As a budding leader in this team, the Clinical Data Manager will be expected to provide ownership and a customer-focused, project-based, clinical data management service to one or more of the Client’s studies, emphasizing the end-to-end support of the complex laboratory clinical data generated by their product’s tests. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

Responsibilities

Lead clinical data management delivery on one or more studies or special projects with minimal supervision including but not limited to:

• Excellent communication and collaboration skills to act as the point of contact for Data Management on assigned studies for internal and external audience of various management levels.
• Proactive approach to prevent problems, ability to apply thoughtful and collaborative problem-solving skills, using good judgment to determine when to escalate and ask for help.
• Apply a data-driven approach to assigned work by utilizing Natera’s standard reports to track study progress and ensure timeliness and quality expectations are met.
• Development and maintenance of data management documents (such as laboratory data management plan, Data Query Plan, and Data Transfer Agreements (DTAs))
• Laboratory Data Transfers
• Ownership of the quality and integrity of the data for assigned studies, by ensuring completeness, accuracy and consistency of the clinical laboratory data and data reports and structure.
• Weekly sample status metrics and/or any other study specific metrics and reports

Experience

• Minimum of 3-5 years of experience in a Clinical Data Management role for medical device, central labs, or in-vitro diagnostic device trials. Experience at a CRO or interventional biotech companies is acceptable.
• The ability to manipulate data through scripting (python, R) and or BI tools (PowerBI) is highly desired but not required.
• Essential skills must include deep knowledge of the clinical data lifecycle for biomarker-driven studies; knowledge of clinical data standards, such as the CDISC; great attention to detail, a proactive mindset, and follow-through on problems as they surface.

EDUCATION

• Bachelor’s degree in life sciences or other relevant discipline, or equivalent domain experience required.

To Be a Best-fit Your Strengths Must Include

• Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment.
• Strong interpersonal skills and communication skills (both written and oral).
• Good organization and planning skills.
• Proficiency Google Workspace apps - the ability to manipulate and analyze data sets with gSheets and/or Excel is required.
• Ability to collaborate with the study team, cross functional team members and external collaborators.
• Familiar with the FDA regulations relevant to clinical trials and laboratory data.

About Advanced Clinical

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience, and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

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