Job Description
Provide clinical programming expertise to support clinical trials, global filings, regulatory queries, data collection, and cleaning.
ResponsibilitiesProvide input from statistical programming to support clinical trials, global filings, regulatory queries, labelling, and payer analyses, as well as scientific communications and publications.Offer subject matter expertise to the design of data collection, data cleaning, SAP, and TFL mock shells.Collaborate with cross-functional groups to ensure the successful execution of clinical trials.Create, validate, or review SDTM, ADaM, and TFLs, mapping specifications, and variable definitions.Review CSR analysis outputs and evaluate submission data packages.Program, test, and document utility programs and tools per standard procedures.Support daily operations, ensuring all assigned project tasks are completed accurately and on schedule.Contribute to departmental process development and process improvement.Essential SkillsProgrammingClinical researchSASPatient Reported Outcomes (PROs)Clinical SystemsData collectionData CleaningBachelor’s Degree in life science, computer science, engineering, business, or related discipline4+ years of experience in clinical developmentExperience with SDTM and ADaMFamiliarity with Patient Reported Outcomes (PROs) and common eCOA systemsKnowledge of good clinical practices, data standards, and regulatory guidance related to PRO and eCOAExperience implementing clinical systems such as CTMS, EDC, ePRO or other related technology in the pharmaceutical/biotechnology industryAdditional Skills & QualificationsProject management and technical expertiseAttention to detailExcellent documentation and communication skillsExcellent time management and organization skillsSound problem resolution, judgment, and decision-making abilitiesGood team player with a result-oriented attitude and can-do mentality
Pay and Benefits
The pay range for this position is $65.00 - $68.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Apr 16, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.