Company Address: Address 168 Third Avenue, Waltham, MA US
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CRA (Level II)
A day in the Life: Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote…
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Clinical Trail Coordinator
Responsibilities: According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix. Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s). Ensures allocated tasks are performed on time, within budget and to a highquality standard. Proactively…
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Assistant CRA – Site Support Solutions
Discover Impactful Work: The ACRA within Site Support Solutions will perform delegated activities at assigned investigator sites under the supervision of the Principal Investigator. Facilitates GCP, protocol adherence, patient safety, quality delivery, and customer satisfaction. Ensures compliance with PPD, sponsor, and site processes, as appropriate. Provides support with regards to site preparedness and logistics on…
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Senior Programmer Analyst
As a Senior Programmer Analyst, you will act as the lead programmer, supervising the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting. Your responsibilities will include (but are not limited to) the following: Programming lead on studies of significant complexity, working directly with project team leaders and client representatives…
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Principal Programmer Analyst – CDISC SDTM Specialist Using SAS
The Data Transformation and Submission(DTS) group within our Biostatistics & Programming department performs active global CDISC submission development for clients in our Biotech, Biopharma and FSP groups. There is also responsibility for Spotfire exploration, SDTM, DSUR reporting, eCRT (Define.xml) as well as cross functional development initiatives with various internal departments, including CDM, Early Dev Services,…
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Associate Medical Director
Summarized Purpose: Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse…
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Assistant CRA
Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned. Completes and documents study-specific training. Orients and trains on any CRG/study-specific systems. Provides in-house support during pre-study assessments and with pre-study asssessment waivers, as agreed for project. Supports to customize Site ICF with site contact details,…
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CRA (Level I)
About the job Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.…
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(Associate) Medical Director Principal Programmer Analyst – CDISC SDTM Specialist using SAS
Summarized Purpose: Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse…
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Principal Biostatistician, FSP (Client-Dedicated)
We are looking for Principal Biostatisticians who implement diverse statistical tasks supporting the clinical development programs. The tasks mainly focus on handling the statistical activities performed by the biometrics CRO and on guarantying by means of thorough review outstanding statistical quality. You will be involved throughout the full clinical trial process, from study design and…