(Full-time position – based in Houston, TX – Hybrid)
Opportunity to work at the cutting edge of an innovative clinical-stage biotech company
COMPANY SUMMARY
March Biosciences, Inc is a clinical-stage cell therapy company with a mission to transform patient care in the most challenging hematological malignancies. Its lead asset is a CAR T-cell therapy showing high efficacy and safety in a Phase I trial for T-cell malignancies, diseases with a dismal prognosis that is currently unaddressed by targeted immunotherapies. With a pipeline designed to expand on these early breakthroughs, March Biosciences is committed to addressing one of the most challenging areas of oncology and delivering hope to patients in need.
JOB DESCRIPTION
Join March Bioscience as we transition MB-105, our CD5 CAR T into a Phase 2 clinical study. We are looking for a Sr. Clinical Research Associate (Sr. CRA)/Clinical Trial Manager (CTM) who will work closely with the Head of Clinical Operations and selected Contract Research Organizations (CRO) to help drive the development and execution of our first Phase 2 trial. Title will be based on the level of experience.
The Sr. CRA/CTM is responsible for the successful planning and execution of March Bioscience’s Phase 2 clinical trial. This includes oversight of the CRO and other study-related vendors as well as managing the cross functional Clinical Trial Team to ensure adherence to the study overall milestones and budget. March Biosciences will maintain a lean team; thus, the candidate must be willing to deliver the operational/tactical work (e.g., conduct ad hoc monitoring visits, QC eTMF, review data, etc.).
This is a high growth, fast paced, small organization. The ability and willingness to “wear many hats” and stretch outside of your specific role to work with a dynamic team to drive our high potential product, MB-105 forward is essential. The ideal candidate is a self-starter with strong organization skills capable of working with a high degree of autonomy and who is eager to make an impact and grow with us professionally.
Below is a summary of responsibilities that may be assigned to the Sr. CRA/CTM by the Head of Clinical Operations:
- Serve as the clinical point person managing operational aspects of trial execution and properly triage escalation issues to the Head of Clinical Operations.
- Oversee performance of CROs, vendors and consultants, to ensure compliance with the trial protocol and timely execution of their scope of work; identify areas of concern and escalate when appropriate.
- Oversee and/or execute on assigned strategic, operational and/or tactical deliverables (e.g., EDC development, TMF QC, sample management at labs, etc.) related to study start up, site start up, study implementation and execution, and study close out.
- Support data management (DM) activities such as reviewing study-related support materials created by DM, including the study manual, edit check manual, clean patient data tracker, listing review process and the SAP; participate in DM related activities (as needed) and data review / cleaning activities throughout the life of the trial; organize/plan data snapshots as necessary for internal and external reviews and data deliveries.
- Support accurate timeline projections, budget management and management of scope changes, escalating issues to Head of Clinical Operations as needed.
- Ensure trial adherence to ICH/GCP, Federal and local regulations, and company SOPs.
- Collaborate with relevant cross functional teams and/or vendors to closely review, monitor and mitigate study risks, issues, KPIs / KQIs (e.g., data metrics, TMF metrics, protocol deviations, site non-compliance, etc.).
- Contribute to clinical project audits and inspection readiness and contribute to CAPAs as required.
- Maintain trial dashboards and documents to ensure accurate tracking and reporting on progress.
- Provide routine status updates to the Head of Clinical Operations and/or cross functional team.
- Responsible for ongoing study communication and escalation of trial-related issues as required; able to identify risks and implement risk mitigation strategies.
- Contribute to the writing and critical review of clinical and cross functional study documents, plans, reports, study plans and manuals.
- Escalate data flow and data quality issues to Head of Clinical Operations.
QUALIFICATIONS
- Minimum BA/BS in life sciences or equivalent college program, and/or commensurate experience in the clinical research industry.
- 8+ years of overall experience in the biotechnology/pharmaceutical industry.
- 5+ years demonstrated work experience of successfully managing clinical trials across Phase 1 to 3 within the biotech / pharma industry, including CRO and contract vendor management.
- Oncology experience required, experience in cell therapy / CAR T trials a plus.
- Strong knowledge in GCP/ICH Guidelines, regulatory compliance, cross-functional clinical processes (e.g., DM, biostats, medical, safety, QA, etc.).
- Ability to supervise, direct and lead team members as well as interact with other internal staff.
- Exceptional skills in the following areas: project management, time management, finance (budgeting, forecasting, etc.), organizational, oral and written communication, conflict management, problem solving.
- Possess advanced computer skills (Microsoft applications, spreadsheets, etc.)
- Ability to work effectively within a team matrix as well as independently.
- Financial management skills as applicable to oversee project expenditures.
- Ability and willingness to travel up to 15-20% (domestic and international)
- Candidates must be based out of Texas, Houston a plus.
Interested Candidates should apply at jobs@march.bio