- UpvoteDownvoteShare Job
- Suggest Revision
Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Manage site regulatory documents and Trial Master File (TMF) The Coordinating Center Senior Project Manager for the Center for Clinical Investigation Coordinating Center (CCI-CC) will report to and work closely with the CCI-CC Director in the development, implementation, and management of the clinical trial operations for ongoing clinical trials and research consortiums.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Guides and ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Identifies and supports the DSPV team with document management activities (e.g., electronic Trial Master File, Veeva) 2+ years of experience in a pharmaceutical industry setting within Drug safety, Pharmacovigilance, or the equivalent.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Responsible for development and maintenance of Trial Master File (TMF),3. Sponsor activities include coordinating trial startup and site startup activities, providing training to participating site research staff, regulatory submissions, safety event tracking and reporting, deviation/violation tracking and reporting, participant accrual tracking and reporting, conducting teleconferences, vendor management, coordinating communication with regulatory authorities and manufacturers, etc.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy. Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
- Suggest Revision
OverviewThe Associate Director, Clinical Operations (TMF, CTMS) is responsible for managing the day-to-day operations of important clinical systems (Trial Master File and Clinical Trial Management) that support clinical trial execution.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
This support includes tracking a wide range of key operational activities and maintenance of essential study documentation, including the electronic Trial Master File (eTMF). The Clinical Trial Associate (CTA) provides clinical trial coordination support to Project Teams for assigned clinical trial(s.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF) Lead both an internal and external/CRO trial management team, to ensure the successful conduct of the trial in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Conversant with statistical programming languages and software, including R/Splus, SAS, RStan, East, FACTS, Spotfire and nQuery; as well as computing tools for modeling, sample size calculations, and clinical trial simulations.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Maintain quality and compliant documentation related to all aspects of site management including quality and ALCOA+ compliant monitoring visit reports, centralized monitoring reports, site contact reports, Trial Master File/Investigator Site File, etc.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Job DescriptionTakeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Master’s degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) The GSM ensures alignment across the study team functions to ensure delivery of study milestones and ensures milestones and study goals are aligned with those of the project team and Trial Operations.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The R&D IT Senior Business Analyst (BA) will play an active role in supporting GXP applications in the Clinical Sciences business area, specifically the electronic Trial Master File (eTMF.
Full-timeExpandApply NowActive JobUpdated Yesterday
trial master jobs in Waltham, MA
FEATURED BLOG POSTS
How to Find a Job That Makes You Happy - 11 Concerning Facts
Do you ever feel like your life is like one of those rom-com movie scene openers? You know, the ones where the main character rolls out of bed, awakened by a casually upbeat theme song, sulks their way to the coffee pot, and then trudges toward their computer to begin yet another boring day at work?
How to Decline a Job Offer You Already Accepted
When you think about it, turning down a job offer is not the worst position you could be in. If you’ve been lucky enough to consider multiple job offers, well, then you’re lucky enough.
How to Practice Fair Chance Hiring for People With Criminal Records
Usually when you think of your dream hire, you think of someone who is respectful, trustworthy, reliable, and has sound judgment, right? As you envision your ideal candidate with these qualities, the last person you think of is someone with a criminal record.
6 Common Mistakes to Avoid When Employer Branding
Currently, job searchers are putting extra effort into researching employers. The information they find plays a major role in whether they will pursue an opportunity with you or look for jobs elsewhere. That is why it is now more important than ever to be proactive and intentional when showcasing your workforce and workplace culture. Having a well crafted employer branding strategy can help you strategize and influence your potential candidates so they see your business in the best light. But in order to do that, you should be aware of some of the most common mistakes that employers make.
What to Say When Terminating an Employee
Terminating an employee is an inevitable part of doing business. Whether you’re re-structuring your department or you’ve identified a few employees who’re not living up to your expectations, letting people go is necessary for keeping your workforce healthy and thriving.
How to Utilize Keywords for Your Job Ads
Before we give you the scoop on how to utilize keywords in job ads, it would be helpful if we defined what keywords are and why they are important. In simple terms,
What Makes a Good Paid Time Off (PTO) Policy
The world of work has undergone some major transformation in recent years. From remote and flexible work to increased emphasis on employee benefits and wellbeing, companies nowadays have to be very intentional about their HR policies and how they approach talent acquisition.