Clinical Research

• Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members.
• Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department.
• Maintain the statistical and analytical integrity of clinical trials analyzed by SDC.
• Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required.
• Support business development and project management with strategic planning, proposals, pricing, and timeline planning.
• Serve as an internal consultant for biostatistics analysis tools and methods.
• Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support.
• Actively support business development in capabilities presentations to prospective and current clients.
• Effectively manage assigned clinical study budgets for biostatistics analysis support.
• Develop, coach and mentor junior biostatistics department personnel.
• Act as the lead statistician on clinical research projects and help with SAS programming.
• Provide statistical expertise for study design of clinical trial protocols.
• Write statistical methods section of the study protocol, as needed.
• Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed.
• Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)
• Program summary tables, data listings and graphical representations of clinical trials data.
• Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data.
• Prepare/review key sections of clinical study reports and various regulatory documents.
• Perform statistical QC of all department outputs including analyses and clinical study reports.
• Provide statistical support to answer questions from external clients (such as FDA, Investigators).
• Contribute to the development, maintenance, and training of standard operating procedures (SOPs).
• Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed.
• Manage biostatistics timelines, budgets, and client expectations.
• Adhere to all aspects of the Statistics & Data Corporation’s quality system.
• Comply with Statistics & Data Corporation’s data integrity & business ethics requirements.
• Perform other related duties incidental to the work described herein.

Principal Biostatistician

• Evaluating and tracking the eligibility of all patients seen in the clinic, EMR reports, or community engagement events
• Obtaining informed consent and registering patients to cohort studies and other protocols.
• Reviewing and abstracting the medical records for patients, including review of pathology reports.
• Entering information into the appropriate EMR and eCRF systems and departmental systems in an accurate manner.
• Reviewing data for quality and completeness based on established queries.
• Assists with the coordination of the collection, processing, organization, and storage of biological specimens in the systems
• May be responsible for IRB and regulatory submissions and maintenance of regulatory files
• Maintaining ongoing communications with research managers and PIs for data collection needs.

Clinical Research Coordinator II, Cancer/Hematology

• In collaboration with other members of the clinical research site team works to ensure the execution of assigned studies.
• Responsibilities may include but are not limited to:
• - Screening of patients for study enrollment;
• - Patient consents;
• - Patient follow-up visits;
• - Documenting in source clinic charts;
• - Entering data in EDC and answering queries;
• - Obtaining vital signs and ECGs;
• - May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
• - Requesting and tracking medical record requests;
• - Updating and maintaining logs, chart filings;
• - Maintaining & ordering study specific supplies;
• - Scheduling subjects for study visits and conducts appointment reminders;
• - Building/updating source as needed;
• - Conducting monitoring visits and resolves issues as needed in a timely manner;
• - Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
• - Filing SAE/Deviation reports to Sponsor and IRB as needed;
• - Documenting and reporting adverse events;
• - Reporting non-compliance to appropriate staff in a timely manner;
• - Maintaining positive and effective communication with clients and team members;
• - Always practicing ALCOAC principles with all documentation;
• - Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
• - Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed;
• - Handles all IRB functions for assigned studies independently, and/or with assigned regulatory team member, as needed;
• - Assist with training of new research assistants and coordinators;
• - Assist with scheduling and planning for visit capacity for assigned studies;
• - May set up, train and maintain all technology needed for studies;
• - May assist with study recruitment, patient enrollment, and tracking as needed;
• - May handle more complex study assignments and volumes;
• - May participate in community outreach/education events;
• - Maintaining confidentiality of patients, customers and company information, and;
• - Performing all other duties as requested or assigned.

Travel Clinical Research Coordinator

• You will be responsible for devising and performing statistical analysis plans
• Communicating the methodologies and results of these to our clients in the healthcare sector
• Work in project teams alongside colleagues from all specialities to ensure that statistics projects are completed to an exceptionally high standard
• Deliver project work requires close collaboration with clients
• Participate in client calls and face-to-face meetings with external stakeholders
• Exposure to a wide variety of services and a broad range of therapeutic areas

Biostatistician

• gain hands-on research experience in partnership with healthcare providers, student-athletes, and researchers
• work directly with healthcare providers at a local high school to administer the CASE to student-athletes recovering from concussion
• play a key role in participant recruitment, screening, enrollment, and informed consent
• scheduling and coordinating study visits
• data collection; regulatory and IRB-related activities; and participant remuneration

Clinical Research Coordinator

• Key member of an early development team, providing leadership in designing and executing early clinical development strategy
• Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs
• Development and execution of studies to validate clinical platforms utilizing established and novel biomarkers
• Provide clinical expertise for identification and validation of novel targets
• Safe and timely execution of Phase I studies
• Provide clear, timely communication and interpretation of study results to therapeutic area governance
• Contribute to assessment of internal and external opportunities identified by Business Development and Licensing
• Interface broadly with key functions throughout research sites around the world

Principal Scientist, Clinical Research

• Provide scientific and strategic biostatistics leadership for oncology portfolio
• Contribute to clinical development plans and study designs
• Serve as the lead statistician for development programs
• Ensure delivery of biostatistics outputs in line with timelines and quality expectations
• Provide statistical leadership for regulatory submissions
• Define and standardize statistical methodologies
• Lead adoption of AI-enabled analytics and automation

Lead Biostatistician, Biostatistics, R&D

• Contribute to the design and statistical sections of clinical trial protocols, including endpoint selection, sample size considerations, and randomization approaches.
• Support analyses of predictive, prognostic, pharmacodynamic, and other biomarker data to inform development decisions and patient selection strategies.
• Participate in the integration and interpretation of clinical and biomarker findings to generate actionable insights.
• Plan, prepare, and execute statistical analyses according to SAPs.
• Generate and review tables, listings, and figures (TLFs).
• Ensure statistical deliverables adhere to CDISC standards (SDTM, ADaM).
• Support clinical study reporting and regulatory documents.
• Collaborate with clinical, data management, and programming teams throughout the study lifecycle.
• Contribute to the evaluation and appropriate use of AI-assisted tools, automation, and advanced analytics approaches that enhance statistical efficiency and insight generation.

Senior Biostatistician, Biostatistics, R&D

• Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out, including feasibility analysis, development of clinical investigation plans, contracts and budgets, timelines, trial oversight, data quality monitoring, and overall study leadership and decision-making.
• Contribute to clinical research strategy, ensuring alignment with intended indications, evidence generation plans, and applicable FDA and international regulatory requirements.
• Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.
• Provide guidance and lead escalations on complex clinical quality, CRO, or vendor performance issues, advising senior leadership to support sound, well-informed decision-making.
• Partner closely across Science collaborators, Product, Engineering, Regulatory, Quality, Clinical Data Management, Legal, and external partners to align study execution with product, clinical, and regulatory goals.
• Translate study requirements into operational plans, including protocol-related planning, study-specific documentation, training, reporting needs, and core study management tools such as dashboards, trackers, and decision logs.
• Work closely with CROs and data management partners to ensure high-quality and auditable evidence generation across eCRFs, EDC build, data review workflows, data cleaning, and database lock.
• Drive study-level strategic decision-making by proactively identifying emerging risks and challenges, developing scenario plans and contingency options, and proposing innovative solutions to keep trials on track when circumstances change.
• Help strengthen and maintain Oura’s Quality Management System by contributing to SOPs, templates, work instructions, and repeatable study playbooks.
• Identify systemic risks or gaps across the clinical portfolio, not just within a single study, and proactively recommend process changes to leadership.
• Mentor and provide operational guidance to Clinical Trial Managers and Clinical Research Coordinators, supporting colleagues as they navigate escalations, ambiguity, and clinical research feedback.

Senior Clinical Trial Manager

• Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out, including feasibility analysis, development of clinical investigation plans, contracts and budgets, timelines, trial oversight, data quality monitoring, and overall study leadership and decision-making.
• Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.
• Partner closely across Science collaborators, Product, Engineering, Regulatory, Quality, Program, Clinical Data Management, Legal, and external partners to align study execution with product, clinical, and regulatory goals.
• Translate study requirements into operational plans, including protocol-related planning, study-specific documentation, training, reporting needs, and core study management tools such as dashboards, trackers, and decision logs.
• Work closely with CROs and data management partners to ensure high-quality and auditable evidence generation across eCRFs, EDC build, data review workflows, data cleaning, and database lock.
• Drive study-level strategic decision-making by proactively identifying emerging risks and challenges, developing scenario plans and contingency options, and proposing innovative solutions to keep trials on track when circumstances change.
• Help strengthen and maintain Oura’s Quality Management System by contributing to SOPs, templates, work instructions, and repeatable study playbooks.

Clinical Trial Manager

• Support the design and execution of multiple clinical studies across the development plan
• Help prepare key trial documents — protocols, informed consent forms, and benefit-risk assessments
• Contribute to CRF design and review completion instructions
• Support study start-up, site opening, and enrollment monitoring
• Review and analyze data listings, patient profiles, and key study data within statistical reports
• Partner with Data Management to generate relevant queries
• Stay current on competitive data and the therapeutic landscape
• Deliver clinical landscape and benchmark updates to the CRD and Project Lead
• Partner with Clinical Leads and CRDs to build presentations for governance committees
• Serve as delegate for the CRD in developing and overseeing the clinical development plan
• Act as liaison across data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs, clinical operations, and translational medicine
• Support project team members, project management, and medical affairs
• Co-author briefing packages for health authority submissions and contribute to regulatory strategy
• Build and maintain relationships with internal collaborators, KOLs, and investigators
• Support interactions with Sanofi governance bodies, external partners, and committees

Senior Clinical Scientist

• Lead the development and drive execution of global category strategies across Clinical Trial Enablement.
• Partner with global and regional senior stakeholders to align procurement strategies with business requirements.
• Participate in cross-functional teams to support global sourcing initiatives that drive efficiency, value, and risk mitigation.
• Leverage spend analytics, market research, and benchmarking to identify cost and value opportunities.
• Track and report savings and value delivered through contracts and sourcing initiatives.
• Monitor supply market dynamics and supplier performance, escalating risks and opportunities as needed.
• Support and lead sourcing initiatives across the end-to-end RFx lifecycle.
• Collaborate with stakeholders to develop fit-for-purpose sourcing strategies.
• Utilize appropriate sourcing channels to drive efficiency and user adoption.
• Support supplier management activities, including onboarding, performance reviews, and issue resolution.
• Serve as a primary procurement point of contact for assigned Medical and Regulatory service areas.
• Build strong working relationships with Medical, Safety, Regulatory, Compliance, and related functions.
• Facilitate effective communication between stakeholders, suppliers, and internal procurement partners.

Senior Category Manager – FSP, Clinical Trial Enablement

• Design and analyze clinical trials and observational studies in collaboration with Clinical Operations, Medical Affairs, Regulatory Affairs, and R&D
• Develop statistical analysis plans (SAPs) and perform statistical analyses using SAS, MATLAB, and R
• Provide statistical input for study protocols, case report forms (CRFs), and clinical study reports (CSRs)
• Ensure statistical deliverables meet regulatory requirements and industry standards (FDA, EMA, ICH-GCP, ISO)
• Provide data summaries to support data integrity and data review during ongoing studies
• Support regulatory submissions with statistical summaries and responses to agency queries
• Contribute to scientific publications and presentations of clinical data
• Stay current with statistical methodologies and regulatory guidelines relevant to medical devices and diabetes research.
• Performs other duties as required.

• Provides strategic input as the lead statistical subject matter expert supporting clinical research studies
• Leads or oversees statistical analyses and application of advanced research methods
• Contributes statistical expertise to research proposals, grant-supported initiatives, protocol development, and scientific publications
• Publishes research findings in recognized scientific publications

• publish content on external website (dcri.org) and intranet (Pulse) using content management systems (Drupal and SharePoint, respectively)
• create graphics for social media, external websites, and intranet
• determine requirements for instructional audiovisual media and coordinate production of slide series, films, videotapes and other media materials for use
• works both independently and collaboratively with internal Shared Services department, Production Designers and Marketing Managers on a wide mix of creative initiatives
• manage calendar of DCRI’s scientific conferences, researching Duke-related presentations at each show
• for scientific conferences at which DCRI has an exhibit booth, coordinate the marketing collateral needed for the booth
• prepares layouts, designs, artwork and formats for use in publication and/or exhibition design
• contribute to editorial planning by suggesting content ideas, target channels and audiences, and appropriate project timelines
• compile weekly internal newsletter in MS Outlook
• create quarterly external-facing newsletters using Constant Contact
• occasional content development for DCRI-owned external and internal channels
• serve as backup manager of DCRI’s social media channels (Twitter and LinkedIn)
• assist in the shooting and production of video and audio projects
• develop a broad knowledge of research conducted at the DCRI

Clinical Research Comm Specialist III

• Execute Bicara’s clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration.
• Support clinical operations team in ensuring all trial deliverables are met according to timelines, budget, operational procedures, and quality standards.
• Work closely with external collaboration partners with a focus on relationship management and efficiency.
• Lead the proactive identification, assessment, and management of clinical study challenges and risks.
• Support the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution.
• Monitor oversight of study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable.
• Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met.
• Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc.
• Participate in Case Report Form design and user acceptance testing in partnership with Data Management as well as data monitoring over the course of the study.
• Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics.
• Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc.
• Contribute to and/or author clinical sections of regulatory documents including Investigators’ Brochures, safety updates, and responses to Health Authority / Ethics Committee questions.

Senior Clinical Trial Manager – Global

• Manage studies to provide safety and efficacy data for regulatory approval of drugs
• Ensure high-quality clinical trials integrating state-of-the-art technology and rigorous ethical standards
• Primary responsibility for planning and directing clinical research activities in Thoracic Oncology
• Manage the entire cycle of clinical development including strategy, study design, execution, monitoring, analysis, and reporting
• Provide scientific leadership and collaborate with cross-functional teams
• Interact externally with key opinion leaders and maintain awareness of scientific developments

Distinguished Scientist, Clinical Research, Thoracic Malignancies

• Collaborate and liaise with external partners (e.g., KOLs).
• Seek out and enact best practices with instruction.
• Provide regular and timely updates to manager/management as requested.
• Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required.
• Conduct literature review.
• Submit clinical documents to TMF.
• Develop site and CRA training materials and present these at SIVs and Investigator meetings.
• Review clinical narratives.
• Monitor clinical data for specific trends.
• Develop Data Review Plan in collaboration with Data Management.
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)

Senior Manager, Global Clinical Scientist – Psychiatry

• In collaboration with other members of the clinical research site team, works to support source document requirements for assigned studies.
• Creation of source documents that will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to internal SOPs.
• Create templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments.
• Initial creation of source documents will use all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided source templates/worksheets, or reference manuals) to create a source document that is accurate and complete and to ensure that the source document is equipped to record all the required data for the visit.
• Creating, maintaining, updating, control, and release source documents, including paper and electronic source documents in line with the study protocol, and relevant sponsor guiding documents.
• Reviewing draft source and ensuring it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial.
• Coordinating initial source review and update process.
• Filing, maintaining, distributing, organizing, and archiving source documents for each clinical trial.
• Updating current source documents according to new clinical study protocol amendments.
• Activating studies and visits at the appropriate time.
• Supporting Quality Control (QC) of source documents before it goes to the users.
• Attending all relevant meetings to stay up to date with upcoming studies, progress on current studies, and studies closing out.
• Maintaining a single tracker for the department to track source document design activities and the status of the activities.
• Maintaining version control of all source documents.
• Managing daily communication with site staff and other internal departments.
• Remaining up to date with all assigned Clinical Study Protocol for study.
• Developing and maintaining excellent working relationships with internal and external clients to understand and meet their needs in line with company policies and procedures.
• Maintaining a positive, results-oriented work environment, building partnerships within the team and across the organization at large, and modeling teamwork.
• Participating in continuing education activities to maintain current knowledge of source document design and relevant software.
• Performing all other duties that may be requested or assigned.

Clinical Research Source Development Coordinator

• Serve as a day-to-day operational point of contact for assigned CROs and vendors, tracking study deliverables and timelines and flagging risks or delays to clinical operations leadership.
• Review CRO-generated study documents for completeness and quality, including monitoring visit reports, site correspondence, protocol deviations, and TMF entries.
• Support the coordination of study startup activities, including site activation tracking, regulatory document collection, and vendor kick-off preparation.
• Maintain and update study trackers, timelines, and action logs; ensure cross-functional teams have visibility into study status and open items.
• Attend and support cross-functional study team meetings; document meeting minutes, track action items, and follow up on outstanding deliverables.
• Track and triage protocol deviations reported by CROs; coordinate with vendors and internal teams to ensure timely documentation and resolution.
• Support safety reporting coordination, including tracking SAE/SUSAR notifications and ensuring timely distribution to sites and relevant stakeholders in line with vendor responsibilities.
• Monitor TMF completeness and support inspection readiness activities, working with CROs to resolve filing gaps and maintain document quality standards.
• Assist with IRB/IEC tracking across study sites, including monitoring approval status for amendments and annual renewals submitted by the CRO.
• Compile and distribute enrollment, site performance, and operational metrics to clinical operations leadership on a regular basis.
• Contribute to data reviews as needed, and track data cleaning progress performed by CRO.
• Review and track monitoring visits and monitoring visit reports performed by CRO to ensure high quality and adherence to the monitoring plan.
• Support vendor invoice review and budget tracking by reconciling CRO invoices against contracted activities and flagging discrepancies.
• Coordinate data reconciliation activities at key study milestones in collaboration with data management and the CRO.
• Support the onboarding of CTAs joining the study team and serve as a resource for day-to-day study questions.

Clinical Research jobs in Massachusetts

See all jobs on JobTailor

Principal Biostatistician

Clinical Research Coordinator II, Cancer/Hematology

Travel Clinical Research Coordinator

Biostatistician

Clinical Research Coordinator

Principal Scientist, Clinical Research

Lead Biostatistician, Biostatistics, R&D

Senior Biostatistician, Biostatistics, R&D

Senior Clinical Trial Manager

Clinical Trial Manager

Senior Clinical Scientist

Senior Category Manager – FSP, Clinical Trial Enablement

Biostatistician

Principal Biostatistician

Clinical Research Comm Specialist III

Senior Clinical Trial Manager – Global

Distinguished Scientist, Clinical Research, Thoracic Malignancies

Senior Manager, Global Clinical Scientist – Psychiatry

Clinical Research Source Development Coordinator

Clinical Trial Manager