Manager, Clinical Data Standards

The Manager, Clinical Data Standards is responsible for developing, implementing, and sustaining global clinical data standards that support high-quality regulatory submissions and the success of the research and development pipeline. This role partners closely with cross-functional stakeholders to optimize data collection services across therapeutic areas, ensuring that data definitions, collection tools, and mapping strategies align with industry standards such as CDISC and health authority requirements. The position requires a hands-on subject matter expert in clinical data standards who can work in a fast-paced environment, drive innovative solutions, and be accountable for delivering high-quality, standards-compliant clinical data. Responsibilities Develop, maintain, and enhance global clinical data standards to support high-quality regulatory submissions across multiple therapeutic areas. Lead activities associated with standards development, management, and implementation within clinical data management functions. Partner with diverse cross-functional stakeholders to optimize data collection services for clinical programs. Define and manage data standards, including data collection and mapping data definitions, to ensure alignment with CDISC and other relevant industry standards. Ensure clinical data collection tools and processes adhere to health authority regulations and submission requirements. Apply working knowledge of various data types and data collection methods, including EDC and non-EDC approaches, to design robust data standards. Implement and manage industry standards such as controlled terminologies, CDISC CDASH, SDTM, and ADaM for clinical data submissions. Serve as a subject matter expert in clinical data standards as they relate to the development of clinical data collection tools. Use expertise in Study Data Tabulation Model (SDTM) to support the design, mapping, and review of clinical data for submission. Utilize hands-on experience with the

RAVE EDC

system, including library build and management, to support standardized study setup. Develop and maintain edit checks in RAVE to ensure data quality and consistency across studies. Collaborate effectively as a team player within cross-functional teams, contributing to planning, problem-solving, and decision-making. Communicate complex clinical data standards concepts clearly through strong verbal and written communication and presentations. Demonstrate a self-starting, solution-oriented, and innovative approach while working in a fast-paced environment and being accountable for results. Essential Skills Minimum of 5 years of experience in clinical data management, data standards, or related clinical research roles within a CRO or pharmaceutical environment. Strong background in clinical data management and clinical research, including experience with data submissions. Working knowledge of various data collection methods, including EDC and non-EDC systems. Direct experience implementing industry standards such as controlled terminologies, CDISC CDASH, SDTM, and ADaM for data submissions. Expertise in Study Data Tabulation Model (SDTM), including practical, hands-on experience. Working, hands-on knowledge of the

RAVE EDC

system, including library build and management. Experience in developing and managing edit checks within the RAVE system. Demonstrated ability to self-start, work independently, and be solution-oriented with an innovative mindset. Ability to work effectively in a fast-paced environment while maintaining accountability for results. Excellent verbal and written communication skills, with the ability to present complex information clearly. Strong analytical and interpersonal skills for collaborating with individuals at different levels and across functions. Proven ability to operate as a team player and interact effectively with cross-functional teams. Additional Skills & Qualifications Prior experience in a contract research organization (CRO) or pharmaceutical company environment. Experience with the development and implementation of global clinical data standards across multiple therapeutic areas. Familiarity with health authority regulations and expectations related to clinical data submissions. Strong presentation skills, with the ability to communicate standards strategies and outcomes to diverse stakeholders. Work Environment This is a remote role with the expectation that the individual is local enough to come onsite as needed, with a maximum of approximately two hours of round-trip commute time. Job Type & Location This is a Contract position based out of Basking Ridge, NJ. Pay and Benefits The pay range for this position is $75.00 - $85.00/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 hybrid position in Basking Ridge,NJ.

Application Deadline This position is anticipated to close on Apr 17, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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 people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.