Current jobs related to Senior Manager, Clinical Trial Transparency and Disclosure - Boston - Cerevel Therapeutics
-
Clinical Trial Manager, Start Up
1 week ago
boston, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Clinical Trial Manager, Start Up
1 week ago
Boston, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Clinical Trial Manager, Start Up
1 week ago
Boston, United States Clinical Dynamix Full timeClinical Trial Manager, Start Up Job Description; (Hybrid in office 3 days peer week)At Company, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic...
-
Project Manager
1 week ago
Boston, Massachusetts, United States Alliance for Clinical Trial in Oncology Foundation Full timeAbout the RoleWe are seeking a highly skilled and experienced Project Manager to join our team at the Alliance for Clinical Trials in Oncology Foundation. As a Project Manager, you will play a critical role in the development, implementation, and oversight of assigned clinical trials.Key ResponsibilitiesManage the development, implementation, and oversight...
-
Senior Manager
2 weeks ago
Boston, Massachusetts, United States Noema Pharma Full timeAbout the RoleNoema Pharma is a clinical-stage biotechnology company focused on developing novel therapies for debilitating central nervous system (CNS) disorders.We are seeking a highly experienced Senior Manager to lead our Clinical Trials Team in the execution of global clinical trials in neuroscience.Key ResponsibilitiesLead Clinical Trials Planning and...
-
Senior Clinical Trial Manager
1 week ago
boston, United States Fusion Pharmaceuticals Full timeFusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio...
-
Senior Clinical Trial Manager
1 week ago
Boston, United States Fusion Pharmaceuticals Full timeFusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio...
-
Senior Clinical Trial Manager
1 month ago
Boston, United States Bicara Therapeutics Full timeRole OverviewThe Senior Clinical Trial Manager works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial...
-
Sr. Clinical Trial Manager
3 months ago
Boston, United States RBW Consulting Full timeJob Title: Senior Clinical Trial ManagerLocation: Boston, MAOur client are a dynamic and innovative biotechnology company at the forefront of cellular therapy. Our mission is to develop cutting-edge treatments that improve patients' lives. Based in the vibrant biotech hub of Boston, we are a small but growing team dedicated to pioneering new therapies and...
-
Clinical Trials Manager
2 weeks ago
Boston, Massachusetts, United States Noema Pharma Full timeAbout the RoleNoema Pharma is a clinical-stage biotechnology company focused on developing novel therapies for debilitating central nervous system (CNS) disorders.We are seeking a highly experienced Senior Manager to lead our Clinical Trials Team, driving cross-functional interfaces and providing direction and guidance for successful trial execution.Key...
-
Clinical Trials Manager
4 weeks ago
Boston, Massachusetts, United States Mass General Brigham Full timeGENERAL SUMMARY/OVERVIEW STATEMENT: The Brain Modulation Lab within the Department of Neurosurgery at Mass General Brigham is in search of a dedicated and detail-oriented Clinical Trials Manager. This role is essential for overseeing clinical studies and research initiatives. The successful candidate will handle all aspects of data and sample acquisition for...
-
Clinical Trial Manager
1 month ago
Boston, United States Inozyme Pharma Full timePosition Overview: We are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate...
-
Biostatistician - Clinical Trials
1 day ago
Boston, Massachusetts, United States Mass General Brigham Full timeJob SummaryThis position involves statistical analysis and programming of large-scale international clinical trials. The successful candidate will have advanced formal training in statistics or biostatistics, including design and analysis of observational and experimental studies, and strong statistical computing skills.Key ResponsibilitiesCollaborate with...
-
Associate Director, Clinical Data Management
2 weeks ago
boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Associate Director, Clinical Data Management
2 weeks ago
boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 3 Days a week in office (2 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Associate Director, Clinical Data Management
3 months ago
Boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Associate Director, Clinical Data Management
3 months ago
Boston, United States Clinical Dynamix Full timeASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...
-
Sr./Clinical Trial Manager
1 month ago
Boston, United States Actalent Full timeJob Title: Clinical Trial Manager Job Description We are seeking a seasoned Clinical Trial Manager with 4-7 years of experience in clinical trial management at a CRO or Pharma/biotech company. Candidates with experience in small companies and oncology are highly preferred. The role involves managing and overseeing multiple CROs and ensuring good clinical...
-
Clinical Trial Lead
1 week ago
Boston, Massachusetts, United States Joulé Full timeAbout the RoleWe are seeking a highly skilled Clinical Trial Lead to join our team at Joulé. As a Clinical Trial Lead, you will be responsible for overseeing the clinical trial process from initiation to completion.Key ResponsibilitiesIdentify and initiate communications with research sites to obtain relevant documents for project/trial.Collect and review...
-
(Lead) Clinical Trial Administrator
5 days ago
Boston, United States Beacon Hill Life Sciences - Boston Full timeJob DescriptionJob Description100% Remote - (Lead) Clinical Trial AdministratorDURATION: through March 2025. There is potential to extend.100% Remote - (Lead) Clinical Trial AdministratorDURATION: through March 2025. There is potential to extend. Experience required: 4+ years as CTA. Must be Senior/Lead LevelSponsor / Pharma experienceExperience with late...
Senior Manager, Clinical Trial Transparency and Disclosure
3 months ago
Boston, MA (Remote)Development – Global Regulatory and Access Solutions /Full Time /RemoteRole Summary:The Senior Manager of Clinical Trials Transparency and Disclosure is responsible for leading and managing Global Clinical Trial Disclosure and Data Transparency activities per applicable laws, regulations, and policies. This role will serve as a subject matter expert and primary point of contact for Cerevel’s transparency and disclosure activities (e.g., clinical trial results postings, document redactions, and layperson results summaries). The Senior Manager will partner with and lead interactions with senior management and team members in relevant functional areas and manage vendors who are directly involved in activities related to disclosure and transparency. The successful candidate must be flexible, detailed oriented, self-directed and manage workload to meet submission timelines across all company programs.Key ResponsibilitiesLead Global Clinical Trials Transparency Workstream and provide vendor oversightIf needed, lead the development of Cerevel’s overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessaryManage the preparation of plain language (layperson) summaries and redaction of clinical documents in accordance with EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other global regulationsEducate and provide company-wide awareness of transparency/disclosure regulations and industry trendsCoordinate efforts of cross-functional teams to produce high-quality, scientifically accurate documents & postings (e.g., plain language [layperson] summaries, interim and/or final results postings, and redaction documents); acting as liaison between the vendor and Cerevel teamsWork on multiple projects/across programs, coordinating work plans that align with corporate timelines and strategic plansLead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, websites, databases, and documentsLead initiatives (including trainings and workshops) and develop/update SOPs, work instructions, and user guides, as neededAdvise on lean writing practices for regulatory documents such as clinical trial protocols and Clinical Study Reports to minimize CCI and PPDAct as a subject matter expert during regulatory inspectionsRequired QualificationsMinimum of 6 years experience in the biotech or pharma industry; including a minimum of 4 years in transparency and disclosure. Advanced degree/academic research or other transferrable skills may be considered in lieu of industry experienceExperience writing or managing plain language (layperson) summaries, results postings, and redactions and understanding of Good Lay Summary Practice (CTEG working Group)Expertise with postings on clinicaltrials.gov and with EU CTR 536/2014 regulationsDeep understanding of US and EU requirements for global transparency and clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.)Experience working with CTIS preferredUnderstands the clinical drug development process, including clinical trial design, operations and results analysisStrong leadership, planning, and project management skills, along with initiative and ability to be productive independently and with minimal administrative supportAbility to evaluate and recommend process improvement and suggest/implement best practicesOutstanding oral and written communication skillsStrong analytical and problem-solving skills; ability to organize/track complex information & prioritizeFlexible; adapts work style to meet organization needsProficient with Microsoft Office products such as (Outlook, Word, Excel, PowerPoint, SharePoint, and Teams), Smart Sheet, Please Review, Veeva Vault, and Adobe SuiteDesired QualificationsRecent neuroscience experience (within 2 years)Experience contributing to outsourcing strategies and vendor selection, including resourcing/budgeting forecasts for assigned projectsPrior experience working in Clinical Development, Clinical Operations, or Medical WritingEducationAcademic degree (BA/BS at minimum) in a relevant scientific or healthcare discipline, advanced degree (eg PhD) in scientific or healthcare field preferred
