Senior Clinical Trial Associate, Inflammatory Bowel Disease Specialist
4 weeks ago
In this pivotal role as Senior Clinical Trial Associate, you will play a crucial part in shaping the future of inflammatory bowel disease (IBD) treatments. Join our dynamic team at Spyre Therapeutics, a clinical-stage biotechnology company dedicated to creating innovative therapies for patients.
Competitive Salary Range: $65,000 - $75,000 per annum
About the RoleThis senior position requires a motivated and detail-oriented individual with a strong background in clinical research. As a key member of our clinical trial team, you will be responsible for the successful execution of trials, ensuring timely delivery and high-quality results. Your expertise will be instrumental in driving our mission forward.
Main Responsibilities:
- eTMF Management: Review and maintain electronic Trial Master Files (eTMFs), performing spot checks and addressing inconsistencies to ensure inspection readiness.
- Meeting and Communication Management: Coordinate logistics for internal and external meetings, prepare agendas, and document meeting minutes.
- Plans and Resource Management: Maintain staff and vendor lists, collaborate with the Clinical Trial Manager on reviewing Trial Master Data (TMD), and contribute to Trial Oversight and TMF Plans.
- Clinical Biospecimen Inventory and Tracking: Lead efforts to manage and track clinical biospecimens, ensuring compliance with regulations and company policies.
- Other Core Activities: Assist with site contracts, trial dashboard updates, and trial budget maintenance, supporting the filing of appendices for the Clinical Study Report (CSR).
Ideal Candidate:
- B.A./B.S. in life sciences or equivalent.
- A minimum of 2 years of clinical research experience, preferably within the pharmaceutical or biotech industry.
- Working knowledge of FDA/ICH guidelines and industry standard practices, including Good Clinical Practices.
- Experience utilizing CTMS, EDC, TMS, and related software preferred.
- Proficient in Microsoft suite of products; Microsoft Word, Excel, PowerPoint, Outlook.
- Attention to detail, excellent organizational and prioritization skills.
- Motivated to work in a fast-paced, high-accountability environment.
- Ability to efficiently perform multiple tasks and manage changing priorities.
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.
We Offer:
- Market competitive compensation package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO.
- Two one-week company-wide shutdowns each year.
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
Lifelancer Platform Partnership: This job posting is brought to you through our partnership with Lifelancer, a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT.
-
Senior Clinical Trial Operations Specialist
4 weeks ago
Waltham, Massachusetts, United States Lifelancer Full timeOverviewSpyre Therapeutics, a clinical-stage biotechnology company focused on developing innovative inflammatory bowel disease (IBD) products, is seeking an experienced Senior Clinical Trial Operations Specialist to join its team. The successful candidate will play a pivotal role in the successful execution of clinical trials and contribute to shaping the...
-
Waltham, Massachusetts, United States Lifelancer Full timeWe are seeking a seasoned Clinical Operations Director to join our team at Lifelancer. As a pivotal role, you will be responsible for executing the clinical operational strategy to ensure all clinical development activities within the company are conducted efficiently and in compliance with local and global requirements.Company OverviewSpyre Therapeutics is...
-
Waltham, Massachusetts, United States Lifelancer Full timeAbout UsSpyre Therapeutics is a dynamic and fast-paced biotechnology company dedicated to creating innovative treatments for inflammatory bowel disease (IBD). We believe in harnessing the power of antibody engineering, rational therapeutic combinations, and precision medicine approaches to drive meaningful progress in the field. As a member of our team, you...
-
Medical Development Lead
1 week ago
Waltham, Massachusetts, United States Lifelancer Full time**Company Overview:** Spyre Therapeutics is a clinical-stage biotechnology company aiming to create next-generation inflammatory bowel disease (IBD) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches.**Job Description**The Senior Director of Clinical Development for Immunology and...
-
Clinical Trial Associate
2 weeks ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeAbout UsBeacon Hill Life Sciences is a leading staffing firm specializing in scientific and clinical talent. With our Boston office, we strive to provide top-notch professionals for your organization.Job Title: Clinical Trial Associate - Study Execution SpecialistSalary Range: $60,000 - $80,000 per year, depending on experienceJob Description:We are seeking...
-
Waltham, Massachusetts, United States Lifelancer Full timeSpyre Therapeutics, a clinical-stage biotechnology company, seeks a Senior Director of Immunology and Inflammation Clinical Development to lead the clinical development strategy and execution for innovative therapies targeting immunological and inflammatory indications.This role requires strong leadership and medical expertise to provide strategic guidance...
-
Senior Biostatistics Manager Clinical Trials
2 weeks ago
Waltham, Massachusetts, United States Apellis Pharmaceuticals Full timeSenior Biostatistics Manager Clinical Trials at Apellis PharmaceuticalsWe are seeking an experienced Senior Biostatistics Manager Clinical Trials to lead our statistical efforts in clinical trials.About the Role:The ideal candidate will have a strong background in biostatistics and experience managing statistical teams. You will be responsible for developing...
-
Clinical Trial Specialist
3 weeks ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeJob OverviewWe are seeking a highly detail-oriented Clinical Trial Associate to join our team in Boston. As a key member of the clinical operations team, you will be responsible for assisting with daily trial execution activities, including document coordination and vendor management.Main Responsibilities:Maintain accurate tracking systems and implement...
-
Clinical Therapeutic Expertise in IBD
2 weeks ago
Waltham, Massachusetts, United States Lifelancer Full time**Job Summary:** As a Senior Medical Director, Clinical Development, you will be responsible for leading the clinical development strategy and execution for innovative therapies targeting immunological and inflammatory indications.**Responsibilities**Providing strategic leadership and medical expertise for the clinical development of our cutting-edge...
-
Clinical Trials Professional
4 weeks ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeJob OverviewThe Clinical Trial Associate supports our Clinical Operations team(s) in the overall management of trials, including planning, execution, and closeout. This fast-paced environment requires strong organizational skills and attention to detail.This is a full-time, 40 hours per week position, fully remote with EST working hours.Prior experience in...
-
Waltham, Massachusetts, United States Lifelancer Full timeClinical Development Leadership OpportunitySpyre Therapeutics seeks a seasoned Senior Director of Clinical Development to lead our clinical development strategy and execution for innovative therapies targeting immunological and inflammatory indications. As a key member of our global clinical development programs, the successful candidate will report directly...
-
Translational Research Immunology Expert
2 weeks ago
Waltham, Massachusetts, United States AbbVie Full timeJob SummaryWe are seeking a highly motivated and creative Principal Scientist to join our Precision Medicine Translational Research Immunology Group at AbbVie. The successful candidate will provide leadership in clinical biomarker strategy and assay development in inflammatory/autoimmune disease areas.Key Responsibilities:Lead cross-functional teams to...
-
Clinical Development Specialist
2 weeks ago
Waltham, Massachusetts, United States Apellis Pharmaceuticals Full timeApellis Pharmaceuticals is seeking a Clinical Development Specialist to support the company's rare disease programs in hematology. As a key member of the medical affairs team, you will develop and maintain peer-to-peer relationships with medical experts to support trial enrollment, provide program and protocol training, and ensure that healthcare...
-
Clinical Trial Manager
2 weeks ago
Waltham, Massachusetts, United States Royalty Staffing Full timeAbout Royalty StaffingOur Company OverviewWe are a dynamic and innovative company, passionate about delivering exceptional staffing solutions to our clients.In this role, you will be part of our Clinical Trials team, which is responsible for managing the execution of clinical studies on schedule and on budget.A Day in the Life of Our Clinical Trials...
-
Medical Research Scientist for Rare Diseases
4 weeks ago
Waltham, Massachusetts, United States Lifelancer Full timeAbout UsLifelancer is a leading talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.Job DescriptionJob Title: Medical Research Scientist for Rare DiseasesLocation: United States (Remote or Hybrid)Contract Type: Full-timeSeniority Level:...
-
Life Sciences Clinical Trials Specialist
1 week ago
Waltham, Massachusetts, United States Lifelancer Full timeAbout the PositionWe are seeking an experienced Clinical Development Scientist to join our team at Viridian Therapeutics. As a key member of our clinical development team, you will contribute to the design, execution, and monitoring of clinical trials, ensuring compliance with FDA and international regulatory requirements.About YouYou have a strong...
-
Clinical Trials Biostatistician Leader
2 weeks ago
Waltham, Massachusetts, United States Apellis Pharmaceuticals Full timeClinical Trials Biostatistician Leader at Apellis PharmaceuticalsWe are seeking a highly skilled Clinical Trials Biostatistician Leader to join our team at Apellis Pharmaceuticals.About the Role:The ideal candidate will have a strong background in biostatistics and experience leading clinical trials. You will be responsible for providing statistical...
-
Research Coordinator
3 weeks ago
Waltham, Massachusetts, United States Beacon Hill Life Sciences - Boston Full timeJob OverviewWe are seeking a highly organized and detail-oriented Research Coordinator to support our Clinical Operations team in Boston. This is a fantastic opportunity to join Beacon Hill Life Sciences, a leading staffing firm specializing in life sciences talent.About the RoleThe successful candidate will work closely with the Clinical Trial Manager to...
-
Clinical Trials Director
1 month ago
Waltham, Massachusetts, United States Royalty Staffing Full timeAbout the RoleWe are seeking an experienced Clinical Trials Manager to join our team at Royalty Staffing in Waltham, MA. This role offers a unique opportunity to lead the execution of clinical studies on schedule and on budget.
-
Clinical Trials Manager Lead
1 month ago
Waltham, Massachusetts, United States Royalty Staffing Full timeAbout the RoleAt Royalty Staffing, we are seeking an experienced Clinical Trials Manager Lead to join our team in Waltham, MA. As a key member of our clinical operations team, you will play a crucial role in leading the execution of clinical studies on schedule and on budget.Job DescriptionThe Clinical Trials Manager (CTM) is responsible for delivering...