Clinical Monitoring Lead
3 weeks ago
Collaborates with Global Asset Lead, Clinical development Lead, Clinical Operations, Global Patient Safety, Biometry & Data Management and any other relevant function to ensure that all development and asset support activities are coordinated and consistent
Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, biostatistics, data management, and pharmacovigilance to ensure quality processes and deliverables
Development and review of clinical study documents ie ICF, protocol updates, CSR
Address routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.
Monitor subject data and communicate with site study teams to obtain updates on subject status.
Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.
Help lead clinical study team meetings and work closely with clinical operations for all aspects of trial conduct
Lead on preparations for Data Monitoring Committee meetings including quarterly safety updates and appropriate slide presentations.
Ensure concise written reports are provided as needed. Helps in data review and interpretation to deliver meaningful efficacy and safety conclusions.
Assist in the review, analysis and reporting of clinical trial data and related publications
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Associate Director, Clinical Operations
3 weeks ago
Cambridge, United States Clinical Dynamix, Inc. Full timeRole: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...
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Clinical Research Physican/Medical Monitor
2 days ago
Cambridge, United States Redbock - an NES Fircroft company Full timeA mid-sized bio-pharmaceutical company in the greater Boston area is looking to add a Medical Monitor to their team. Our client is working on accelerated timelines for a program and they are experiencing an immediate need for hands-on support. This consultant will serve as a scientific resource for study teams, departments, and others as needed. This is a...
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Clinical Research Physican/Medical Monitor
2 days ago
Cambridge, United States Redbock - an NES Fircroft company Full timeA mid-sized bio-pharmaceutical company in the greater Boston area is looking to add a Medical Monitor to their team. Our client is working on accelerated timelines for a program and they are experiencing an immediate need for hands-on support. This consultant will serve as a scientific resource for study teams, departments, and others as needed. This is a...
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Real World Evidence Clinical Lead
3 weeks ago
Cambridge, United States Sarepta Therapeutics Inc. Full timeThe Real World Evidence (RWE) lead provides clinical leadership for evidence generation activities, supporting the integration of RWE into Sarepta key strategic initiatives. The role functions in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality...
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Director, Clinical Science Lead
3 days ago
Cambridge, United States Bayer Inc. Full timeAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
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Clinical Engagement Lead
3 weeks ago
Cambridge, United States TalentBurst, Inc. Full timeClinical Engagement Lead Cambridge, MA 1 year contract Job Description : The site Engagement Leader builds partnerships and commitment by active elicitation of information on site specific processes and feedback on trial design. During the trial, sustained engagement encourages bidirectional communication and facilitates learning networks for enhanced...
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Clinical Development Lead
4 weeks ago
Cambridge, United States Bristol-Myers Squibb Full time**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Clinical Development Scientist
5 days ago
Cambridge, Massachusetts, United States Philips Full timeJob TitleClinical Development Scientist (Cambridge, MA)Job DescriptionClinical Development Scientist (Cambridge, MA)The Clinical Development Lead will primarily focus on study design strategy for the development of clinical study protocols and support the clinical operations team with study execution. This person will apply epidemiology principles and...
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Clinical Project Manager
2 weeks ago
Cambridge, United States Relay Therapeutics Full timeThe Opportunity: As Clinical Project Manager, you will be accountable for managing clinical studies that will lead the biopharma industry in speed and quality of clinical study design and execution. You will be an integrated member of the Relay Tx scientific team, responsible for the execution of clinical studies that will translate Relay's innovative...
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Sr Clinical Research Scientist
3 weeks ago
Cambridge, United States Aequor Full timeJob DescriptionJob DescriptionWe're looking only for a Senior level Clinical Research Scientist. Location is Hybrid, a minimum of 2 days onsite in Cambridge MA.This role is key to help the medical supervision of clinical studies by Clinical Research Directors (CRD) and to ensure scientific management of clinical studies to be performed by the Clinical &...
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Medical Director, Clinical Development
3 weeks ago
Cambridge, United States Beam Therapeutics Inc. Full timePosition Overview: The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies in hematology. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support...
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Medical Director, Clinical Development
2 weeks ago
Cambridge, United States Beam Therapeutics Inc. Full timePosition Overview: The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies in hematology. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support...
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Clinical Project Associate
3 weeks ago
Cambridge, United States Relay Therapeutics, Inc. Full timeThe Opportunity: As Clinical Project Associate, you will be accountable for providing clinical trial coordination support, along with implementing operational plans in accordance with regulatory guidelines and ICH/GCP standards. You will be an integrated member of the Relay Tx Clinical Development Operations team making key contributions to the execution of...
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Director, Clinical Science
3 weeks ago
Cambridge, United States Foghorn Therapeutics Inc. Full timeOur Culture: Why work with us? At Foghorn Therapeutics, we believe in "People First, Mission Always." We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics - demonstrated by our community...
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System DevOps Administrator
2 days ago
Cambridge, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionSenior Systems AdministratorHybrid positionClient's Enterprise IT, R&D Solutions organization is offering a tremendous opportunity for a Senior Systems Administrator to join a new technology-focused, exciting, and state-of-the-art life sciences research facility in Cambridge, MA. This hands-on role will be developed to take...
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Senior Clinical Trial Manager
3 weeks ago
Cambridge, United States Boston Pharmaceuticals Full timeCompany Overview Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...
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Director, Clinical Operations
3 weeks ago
Cambridge, United States Boston Pharmaceuticals Full timeCompany Overview Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being studied in a Phase 2 clinical trial for metabolic dysfunction-associated...
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Safety Specialist
1 month ago
Cambridge, United States QData Full timeRoles & Responsibilities Monitor manage and ensure delivery of projects in a deadline-driven environment. Author Technical SDLC deliverables Technical assistance for testing preparation and implementation of enhancements Contribute to the creation of operational support documentation Drive technical delivery and accountability of internal staff as well...
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Director, Clinical Supply Chain
1 month ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with...
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Director, Clinical Supply Chain
2 days ago
Cambridge, United States QurAlis Full timeABOUT THE COMPANY Do not wait to apply after reading this description a high application volume is expected for this opportunity. QurAlis is a clinical-stage biotechnology company developing breakthrough precision medicines for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets. QurAlis is...