[Hiring] Senior Clinical Trial Manager @Definium Therapeutics

Role Description

The Senior CTM role sits within the Clinical Operations Department at Definium Therapeutics and provides site and/or country level management as well as vendor/external service provider oversight and management. As a Senior CTM, this role may be assigned as the Clinical Operational Trial Lead on a clinical trial, with oversight by the Senior Director/Executive Director of Clinical Operations within the organization.

• Provides operational oversight at the site level and/or country level (for larger late phase trials).
• Responsible for oversight and management of external service providers/vendors, ensuring high-quality deliverables, within agreed upon timelines and budget, and in alignment with all applicable SOPs and regulatory requirements.
• If assigned as the Clinical Operations Trial Lead for a trial, responsible and accountable for ensuring successful cross-functional delivery of the trial, from draft protocol synopsis to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results.
• Ensures ongoing inspection readiness, data integrity, and overall data quality according to corporate and project/program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, and other applicable federal (FDA) and state regulations.
• Assists in the development and review of Clinical Operations Department SOPs, Plans, and Systems build.
• Leads process improvement initiatives, creates processes not currently in place, including the creation of site/trial management tools.
• Serves as a key liaison for outsourced trials to a CRO with oversight and delivery of the transferred obligations and responsibilities.

Qualifications

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 6 years clinical trial experience in the pharmaceutical industry or CRO.
• Experience with managing clinical trials or prior experience in a senior CRA role, ideally in the psychiatric space.
• Willingness and ability to travel up to 20% of the time, defined by business needs.
• Strong organizational skills, attention to detail, and the ability to work effectively in a fast-paced and dynamic environment.
• Clinical research operational knowledge, project planning/management, communication, and presentation skills.
• Experience managing teams in a virtual environment is required.
• Experience in vendor management strongly preferred.
• Excellent leadership skills and proven ability to foster team productivity and cohesiveness.

Requirements

• Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
• Employees in this role may be entitled to additional compensation, including bonus and equity.

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents.
• 401(k) program with company match and vesting after the turn of the first month after your start date.
• Flexible time off.
• Generous parental leave and some fun fringe perks!

Company Description

Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.

Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.