Looking to work day to day with a team of clinical and data analytics experts or join a global network of clinical research professionals? DZS has opportunities to help you fulfill either of these goals.

Available openings

Clinical Project Manager | Statistical Programmer | Clinical Data Manager | Clinical Research Associate

Clinical Project Manager

The Clinical Project Manager is responsible for the coordination and completion of projects by overseeing tasks, timeline and resources necessary to execute project deliverables ensuring project stays on time and within budget.

Responsibilities include, but are not limited to:

  • Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders
  • Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion
  • Lead and facilitate meetings such as kick off meetings, planning sessions and other coordination meetings
  • Set and continually manage project expectations with team members and other stakeholders
  • Plan, schedule, and track project budget and scope, timelines and milestones using appropriate tools
  • Determine the frequency and content of status reports from the project team, analyze results and troubleshoot potential risks/issues
  • Develop best practices and tools for project execution and management
  • Delegate task and responsibilities to appropriate personnel
  • Identify and resolve issues and conflicts within the project team
  • Develop and deliver progress reports, proposals, requirements documentation and presentations as required
  • Proactively manage changes in project scope, identify potential risks/issues and create contingency plans to mitigate risks/issues

Qualifications Include:

  • Excellent oral, written, and presentation communication skills
  • Ability to bring project to successful completion
  • Adept at conducting research into project related issues and products
  • Strong ability to learn, understand and apply new technologies, concepts, practice and procedures related to medical group operations
  • Have intermediate to advanced knowledge of project management software
  • 3-5 years project management experience
  • 3-5 years healthcare industry experience
  • Bachelor’s degree in business, health administration, public health or related field

Statistical Programmer

The Statistical Programmer will be an integral member of a group of statistical programmers making a direct impact on the phases of drug development.

Responsibilities include, but are not limited to:

  • Serve as the core project team member to design and specify the overall approach to a project’s programming tasks
  • Support statisticians with computer programming tasks
  • Generate summary tables and data listings, produce graphs, and process lab data, as specified in statistical analysis plan
  • Generate derived SAS datasets for all parameters and ensure consistency among tables/listings
  • Generate clinical study report tables as well as ISS/ISE tables for FDA submission
  • Create, test and maintain SAS programs for clinical studies according to departmental standard procedures

Qualifications Include:

  • 4+ years of statistical programming experience in a CRO and/or pharma. CRO experience is highly preferred
  • Bachelor’s Degree and/or Master’s Degree preferred
  • Experience creating SAS Macro programs from scratch
  • Strong attention to detail
  • Well versed in CDISC (SDTM and ADaM) and/or CDARS

Clinical Data Manager

Responsibilities include, but are not limited to:

  • Provide Clinical data management support to Clinical Operations team and/or study project, Clinical Data Management team and Biostatistics team.
  • Participates in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).
  • Develops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
  • Develop Case Report Form (CRF), electronic and/or paper.
  • Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
  • Lead EDC database (DB) specification process
  • Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
  • Reconcile electronic data transfers from vendor to Sponsor.Develop test scripts and execution logs for User Acceptance Testing (UAT).
  • Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
  • Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.
  • Perform training on study trial for EDC and create user guides.
  • Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/orcoding.
  • Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
  • Coordinate the archiving of study databases and related documents.
  • Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
  • Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
  • Assist and provide input into study and project level data analysis plan.
  • Coordinate and communicate with DB vendors on consistent basis to address Clinical teams requests, project plans, and/or eCRF development activites.
  • Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems.
  • Participates in the preparation and presentation of data, when applicable.
  • Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
  • Participate in conference calls and/or meetings with vendors.

Qualifications Include:

  • Bachelor’s degree in a science related field.
  • At least two (5) years data management and/or related work experience in a medical device or pharmaceutical industry/company.
  • Working knowledge of Good Clinical Practices, Good Clinical Data Management Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Working knowledge of Clinical database applications such as EDC and CTMS.

Clinical Research Associate

As a Clinical Research Associate, you will take ownership of the monitoring functions on projects with proper planning, timely initiation and completion of high quality documentation, and work with our project management team to ensure that protocol requirements, deliverables and regulatory guidelines are met.

Responsibilities include, but are not limited to:

  • Providing input to the monitoring plan
  • Conducting clinical monitoring visits, (ie, pre-study, initiation, interim and close-out) which includes all preparatory and follow-up aspects with a range of travel at 50-75% (approximately 10 days per month, e.g. for assigned site visits, investigator meetings, co-monitoring)
  • Trip report review
  • Attending weekly sponsor/project management teleconferences
  • Involvement in initial review of study documents
  • May present at Investigator’s Meetings
  • Monitoring site performance and compliance and providing management with necessary reports, updates, and recommendations
  • Preparing clinical sites for regulatory agency audits
  • Assisting sites and data management with data query resolution

Qualifications Include:

  • Candidate must have at least 2 years of proven success in monitoring clinical trials
  • Experience in Phase II and Phase III is a plus
  • Experience with CTMS and EDC systems
  • Bachelor’s degree, preferably in a sciences or health related field is required
  • Highly organized and detail-oriented
  • Computer literate, with strong problem solving abilities
  • Excellent written and verbal communication skills
  • Background in diverse therapeutic areas is preferred

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