Job description
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
Company Differentiators:
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
GENERAL SUMMARY :
4DMT seeks a motivated and experienced Associate Clinical Trial Manager support the Company’s clinical trial activities. This position will be responsible for supporting the day-to-day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close-out activities. This role requires strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines. This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.
MAJOR DUTIES & R ESPONSIBILITIES :
- Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management
- Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing
- Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
- Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample and investigational product tracking
- Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
- Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines
- Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’ (site updates/changes)
- Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)
- Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
- Assist with the development of site tools and clinical trial start-up activities
- Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
- Assist in tracking of trial IP and development of Pharmacy Manuals
- Participate in study vendor set up and specification process, as appropriate
- Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities
- Assist with tracking of clinical trial progress including status update reports, as requested
- Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking
- Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation
- Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates
- May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues
- Willing to travel as business needs demand (% anticipated)
- Other duties as may be assigned
QUALIFICATIONS :
Education:
- A./B.S. degree required
Experience:
- At least 5 years of work experience supporting clinical trials
Other Qualifications/Skills:
- Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
- Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook
- Ability to prioritize and manage competing priorities
- Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
Travel: 30%
Physical Requirements and Working Conditions:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $120,000/yr – $166,000.00/yr
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
