Clinical data manager Jobs in Frisco, TX

Company Overview :

Nulixir, a nano-biotechnology start-up, is a VC-backed business-to-business (B2B) company that develops, manufactures, and licenses intellectual property (IP) for smart nanocarriers, called nanovesicles, which optimize the performance of functional ingredients in food & beverage products. Nulixir, as the Function HouseTM, is revolutionizing the functional ingredient space by introducing a realm of functionality and shaping the future of intelligent food. This patented technology (70+ patents) has applications across multiple verticals in food and beverage (e.g., nootropics, energy stimulants, vitamins, probiotics, protein, etc.).

Founded in 2019, the company brought together a team of CPG leaders, cancer researchers, US attorneys, and nutritionists to overcome long-standing challenges in the Food and Beverage Industry. The firm’s founder has extensive experience in the development of nanocarriers for cancer therapeutics.

In the past-year, Nulixir sales have grown ~8x with strong interest from small, mid-size and many large CPG companies to partner with Nulixir and incorporate the technology in their products. Nulixir boasts an impressive board of senior executives from companies like Pepsi, Danone, McKinsey & Company, Paine Schwartz Partners, etc. The company currently has 30+ employees with a stellar executive team who come from food B2B companies such as ADM, Givaudan, Kerry, and ex-MBB consultants.

Position Overview :

We are seeking a detail-oriented and organized Clinical Trial Manager to plan and coordinate clinical trials for food and beverage products and ingredient testing.

The Clinical Trial Manager’s responsibilities include designing and writing protocol, monitoring the trials, ensuring adherence to regulations, and compiling and presenting findings.

The ideal candidate will have a strong understanding of Good Clinical Practice (GCP) guidelines and will ensure all trials are conducted ethically and under these regulations.

Position Location :

This position will be IN-PERSON at our HQ facilities located in the Austin, TX Metropolitan Area.

In this critically important role, you will be responsible for :

• Manage the implementation, on-time execution and conduct of Nulixir’s food & beverage clinical trial studies
• Facilitate and manage pre-study, site qualification, study initiation, monitoring visits, and study close out activities
• Manage the development of study plans, timelines, IRB approval, 3rd party partner selection as well as ensuring quality and compliance
• Develop detailed project plan for logistics of each trial (e.g., inventory, BSL2, participant room) and executes them in a timely manner
• Ability to identify potential risks that may impact the studies, e.g., study data, ethical conduct and adherence to ICH guidelines and provides risk mitigation solution.
• Work with R&D team in proactively maintaining / updating essential documents as required, to ensure compliance with protocol and regulations in accordance with GCP.
• Lead development of study plans and system set-up; ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
• Author, audit and / or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals), including for IRB submission.
• Lead patient recruitment and retention through follow up.
• Find solutions to increase patient recruitment by debottlenecking any challenges faced through each stage – registration, pre-screening, screening, and scheduling
• Support the safety of research subjects and report adverse events.
• Support literature research for active ingredients of interest
• Understand the data requirements of clinical studies to ensure quality and integrity of data during collection, review, cleaning, and monitoring.
• Develop and maintain budgets for clinical study.
• Perform duties with minimal supervision and has the ability to partner with and lead other members of the team to complete deliverables on time.

Relevant Job Experiences, Skills, and Key requirements for this role :

Excellent organizational and interpersonal, oral, and written communication skills in English

Preferred experience in conducting and / or managing small / large scale clinical trials

Ability to work independently and lead and motivate a team

Demonstrate initiative and problem-solving skills by offering solutions.

Strong customer focus, ability to interact professionally.

Ability to manage multiple priorities within various clinical trials.

Proficiency in Microsoft Office and other tools

Working knowledge of current ICH GCP guidelines and applicable regulations.

Bachelor’s Degree required

1+ years’ experience as a Clinical Trial Manager, Clinical Operations Leader, Lead CRA, or equivalent role

2+ years’ experience as a Clinical Research Associate

Phlebotomy experience preferred

Pay Range :

90K - $120K

Why Join Nulixir?

Innovative Environment - Be part of a pioneering company at the forefront of food and beverage innovation.

Impactful Role - Play a crucial role in the company’s growth and success by supporting the CEO.

Growth Opportunities - Access to professional development and career advancement opportunities within a dynamic and growing company.

Collaborative Culture - Work with a passionate and driven team dedicated to making a difference in the industry.

Competitive Compensation - Enjoy a competitive salary and comprehensive benefits package.

Nulixirians’ Culture :

We recruit, promote, and reward based off of our five core values :

Sleeves Up - At Nulixir, we provide the autonomy and creativity needed to own your role, iterate where needed and drive impact on a massive scale.

100% Transparency - Nulixir is passionate about open feedback at all levels of the company. This allows us to fail fast, create in real time and build an open company culture.

Be Defiantly Grea t - We are defiant, that’s in our lifeblood, we accomplish what other people think are impossible. Challenging the status quo is our lifeblood.

Unconditional Empathy - Our customers are real people with real business needs, and we are here to listen and tackle accordingly. If we care and respect each other, there is no challenge we can’t overcome.

Be the solution, not just the critic - take ownership and drive collaboration. We work together and we build together.