Job description

Sr. Clinical Trial Associate (Sr. CTA)

Clinical Development Operations

A publicly traded, clinical-stage biotechnology company is developing life-changing medicines using advanced structure-based and computational drug discovery technologies. The company’s platform integrates molecular visualization, computational chemistry, and data science to design orally available small-molecule therapies that address limitations associated with biologics and peptide drugs.

The organization is advancing a differentiated pipeline focused on chronic diseases with high unmet medical need, including cardiovascular, metabolic, and pulmonary indications. The company is led by an experienced team of global drug developers and supported by top-tier life sciences investors, with research and development operations across the U.S. and Asia.

POSITION SUMMARY

The Sr. CTA serves as a central contact for the designated clinical study team and provides key operational support in the planning, implementation, and completion of clinical studies (both outsourced and internally managed). This role interfaces with investigative sites, vendors, and cross-functional internal stakeholders.

The Sr. CTA works independently under the direction of Clinical Operations leadership and exercises sound judgment in determining when to escalate or collaborate with functional partners. This is an individual contributor role within the Clinical Operations organization. Hybrid or remote work arrangements may be considered.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Obtain, review, process, and track study-related documents (e.g., investigator CVs, FDA 1572s, laboratory certifications, IRB approvals, contracts, protocols, etc.)
Set up, maintain, and close out the Trial Master File (TMF/eTMF); perform quality control reviews and resolve discrepancies
Maintain and update study metrics, including visit reports, regulatory documentation, site and team contact lists, and vendor trackers
Prepare meeting agendas and document comprehensive minutes for internal and external meetings
Track study-level activities such as monitoring visits, sample shipments, and clinical supplies
Assist with preparation of materials for investigator meetings, monitor workshops, and study manuals
Coordinate with cross-functional teams to ensure accurate and timely completion of regulatory documents and facilitate handoff to Regulatory Affairs ahead of submission deadlines
Support information exchange across departments to ensure timely execution of study deliverables
Assist with data reconciliation activities as needed
Participate in review of clinical database outputs, listings, and reports as assigned
Maintain public clinical trial postings (e.g., clinical trial registries)
Support management of clinical trial insurance documentation, including tracking renewals and policy updates
Prioritize workload effectively to meet critical study timelines
Perform additional responsibilities as required by study needs

REQUIREMENTS

Education

Bachelor’s degree in a scientific or related discipline

Experience

Minimum 2+ years of experience in biotechnology, pharmaceutical, or clinical trial management environments; global trial experience preferred
Experience working in an electronic TMF environment
Strong communication and interpersonal skills
Excellent organizational skills with strong attention to detail
Ability to manage multiple priorities in a fast-paced environment
Proficiency in Microsoft Office applications (Word, Excel, etc.)

Travel

Up to 20%