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4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.
Associate Clinical Trial Manager (Temporary)
Location
United States
Posted
65 days ago
Salary
$62 - $72 / hour
Seniority
Lead
No structured requirement data.
Job Description
Associate Clinical Trial Manager (Temporary)
4D Molecular Therapeutics
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 leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY: 4DMT seeks a motivated and experienced Associate Clinical Trial Manager to support the Company's clinical trial activities. This position will be responsible for supporting the day-to-day operations of one Phase 3 clinical trials including trial 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 & RESPONSIBILITIES: - 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 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 - Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers - Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance - 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 - Communicate directly with sites handling triages, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with 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 - 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 - 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: 20% 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: $62.00-72.00 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
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EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: This is a field-based position, supporting Abbott’s Vascular division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices, peripheral stents, thrombectomy catheters, and atherectomy devices. We currently have an opportunity for a Clinical Specialist, Vessel Closure, in North Boston. The Clinical Specialist will primarily be responsible for case planning, case support coverage, and product pull- through throughout the designated territory, and throughout the Region as needed. The Clinical Specialist will promote Vascular products through education, service and training of customers in the hospital setting. The Clinical Specialist will provide clinical education and sales support in order to assist in achieving projected sales goals, increasing sales revenues within assigned product lines, and increasing market share. This position will have a heavy focus on Vessel Closure. What You’ll Work On: - Serves as the technical procedure and product expert in support of case coverage in the hospital setting. - Focuses on Electrophysiologists and Interventional Cardiologists and hospital staff to support the complete Vessel Closure portfolio, including small and large bore arterial, venous, and future product releases. - Meet with existing and potential customers (e.g., physicians, physician office groups at hospitals) to identify their clinical needs, goals, and constraints related to patient care and to discuss and demonstrate how Vascular products can help them to achieve their goals. - Develop relationships with hospital personnel; make new contacts in hospital departments; identify key decision makers. - Serve as primary resource for clinical support in case coverage, troubleshooting and in-service education for company products. - Educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals) to keep all customers abreast of the latest product, therapy, and technology developments and current items of interest in the industry. - Attend clinical procedures in the Cardiac Cath Lab, Interventional Radiology Lab, and Operating Room to ensure customer and patient success with Vascular products. - Respond to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g., sales, clinical research, marketing, product development) to develop optimal solutions. - Support the broader Region as needed with case support in addition to the defined territory. Required Qualifications - Bachelor’s degree or equivalent combination of education and experience - 2-5+ years of related work experience - Ability to travel 50% within the assigned region Preferred Qualifications - Patient interaction experience within a lab/operating room environment - Relevant Technical Certification The base pay for this position is $68,000.00 – $136,000.00In specific locations, the pay range may vary from the range posted. JOB FAMILY: Sales Force DIVISION: AVD Vascular LOCATION: United States of America : Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 50 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
