Clinical System Analyst

Job Details:

• Job Title: EDC Lead / ADC Programmer / Clinical System Analyst
• Location: Remote
• Duration: 12 Months
• Tax Term: W2

Notes from hiring Manager:

Prefer in NJ or close to other client's office- Open to any location in US if they have the right experience

Contract: 1‑year contingent, possible 2‑year extension, conversion to full‑time FTE after 1 year based on performance.

Ideally they want to convert this someone perm after a year. If converted to full time they want candidate to be in NJ for hybrid schedule

This is Sytem Design Analyst III position- this role is EDC programmer/ EDC Lead (hands on, not management)

Metadata Rave is ideal- but would consider other candidates with good hands on work ( viva, etc?)

Hands on experience design study, read protocol, understand how to create EDC specification and then coordination across study team members- Coordinate with minitor team, clinical science, statistical and gather all the info and collect the information and put in EDC specification and design the study into RAVE EDC.

STDM and CDISC- strong hands on experience

6-7 years of experience atleast- BS degree minimum

3 days onsite HYBRID – must be close to client's facility- prefer NJ but open to others

Would you take a PHD candidate with 3-5 years?

Rave experience a MUST

Ideally they want to convert this someone perm after a year. That is why they prefer someone local to an AbbVIe site

• Required Experience & Education
• Minimum: 6‑7+ years relevant experience; Bachelor’s degree required.
• PhD candidates with 3‑5 years experience acceptable if strong skill set.
• Hands‑on experience with study design, protocol reading, ADC/EDC specification creation.
• Technical Skillset
• Proficiency with Medidata Rave (Viva acceptable as a secondary skill).
• Knowledge of SDTM/CDISC control terminology, variable OIDs, form OIDs, and domain mapping.
• Ability to integrate with IRT and downstream systems, manage bug‑tracking, and ensure data quality.
• Experience in cross‑functional coordination (data monitoring, clinical scientists, statistics).
• Soft Skills & Leadership
• Strong protocol‑reading ability (5‑6/10 baseline; 8‑9 preferred).
• Effective communication, coordination, and leadership in multi‑disciplinary meetings.
• Capability to train junior staff and manage bug‑tracking systems.
• Therapeutic Area Exposure
• Preferred areas: aesthetic, eye‑care, specialty, phase‑1 portfolio.
• Also supports immunology, neurology, oncology; any therapeutic area acceptable.
• Certifications & Additional Qualifications
• Medidata Study Builder certification not required but considered a plus.
• Additional qualifications beyond the core skill set viewed as advantageous.
• Contract Details Clarification
• Contract is one year with a high likelihood of conversion to full‑time after successful performance.
• Extension to a second year possible if additional evaluation needed.
• Hybrid work expectations apply to both contingent and full‑time hires.

Purpose:

Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy Organization.

Responsibilities:

• •Actively participates in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements. Ensures that the design team utilizes standards
• •Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards. Ensures that systems are specified to optimize functionality, end user experience, and data flow. Ensures that the design team meets these expectations
• •Ensures that TA- and program-level consistency is achieved by the design team
• •Accountable for the on-time design and delivery of new clinical systems, integration between systems, as well as any required changes to clinical systems (e.g., EDC, IRT, ePRO). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• •Interacts with and influences CDO and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
• •Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• •Responsible for coaching and mentoring members of the team, as well as contributing to their skill development
• •Leads CDO and cross-functional innovation and process improvement initiatives
• Qualifications
• •Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
• •Must have 7+ years of hands-on technical Study build in EDC. Experience with technical study build in Medidata RAVE is required. Veeva EDC technical study build experience is a plus.
• •In-depth knowledge of clinical trial processes.
• •In-depth knowledge of CDASH (Required) and SDTM.
• •Demonstrated performance as a key contributor to initiatives and advancement of the organization.
• •Demonstrated ability to influence others without direct authority. Demonstrated ability to successfully coach / mentor in a matrixed environment. Demonstrated effective communication skills and analytical skills.

EEO

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”