Clinical Data Specialist

MDC Associates, Inc.; Beverly (MA); À distance; USD 70 000 - 75 000; Plein temps

Avantages offerts par ce poste

Employee Stock Options

Medical, Dental, and Vision Insurance

401(k) with Safe Harbor Match

Unlimited PTO

13 Paid Holidays

Résumé du poste

A clinical research organization is seeking a Clinical Trial Data Specialist to manage data-related activities in clinical trials. This remote role involves ensuring the collection, integration, and analysis of high-quality data while collaborating with teams to maintain compliance with regulatory standards. Applicants should have at least a Bachelor's degree and 2+ years of experience in clinical data management. Competitive salary and benefits, including employee stock options and unlimited PTO, are offered.

Qualifications

• 2+ years of experience in clinical data management or analysis.
• Hands-on experience with EDC systems and data validation tools.
• Familiarity with FDA, EMA, and ICH-GCP regulations.

Responsabilités

• Manage clinical trial data collection, cleaning, and validation.
• Ensure data compliance with protocols and regulatory guidelines.
• Collaborate with teams to ensure accurate and clean data.

Connaissances

Clinical data management

Data analysis

EDC systems

Statistical software

Data visualization tools

Analytical skills

Formation

Bachelor’s degree in Life Sciences, Health Sciences or related field

Outils

MedNet

Medidata

Veeva Vault

Python

SAS

R

Power BI

Description du poste

MDC Associates (MDC) is a full-service CRO dedicated to supporting innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market that impact the lives of millions of patients around the world. Initially founded to provide Regulatory and Quality guidance, we identified a need for highly skilled Clinical Affairs, Clinical Operations, and Data Management services and built our CRO to best ensure our client's success. We're proud of our 35+ year track record providing guidance and resources that have helped to deliver next-generation advances in microbiology, clinical chemistry, infectious disease and companion diagnostics (CDx) that contribute to a healthier world.

The Clinical Trial Data Specialist is responsible for managing data-related activities in clinical trials, ensuring the collection, integration, and analysis of high-quality data throughout the trial lifecycle. This role supports both the data management and analytical functions, ensuring compliance with regulatory requirements, trial protocols, and Good Clinical Practice (GCP) standards. As part of the data team, the Clinical Trial Data Specialist will collaborate closely with the Senior Data Manager and Clinical Operations team to ensure that trial data is accurate, clean, and ready for analysis

Primary Responsibilities

• Collaborate with Senior Data Manager to manage clinical trial data collection, cleaning, and validation processes.
• Work with data management team to design, implement, and maintain data collection systems (e.g., electronic data capture (EDC)).
• Ensure that data is entered into EDC according to protocol and regulatory guidelines.
• Ensure proper tracking of queries and data discrepancies and support resolution.
• Ensure the accuracy and completeness of trial data before database lock.
• Perform preliminary data analysis to support interim or final clinical trial reporting.
• Assist in the creation of clinical trial reports, including tables, listings, and figures.
• Conduct exploratory analysis as needed to support clinical decisions.
• Ensure compliance with ICH-GCP, FDA regulations, and other applicable guidelines and standards.
• Work with Senior Data Manager to develop and review data management documentation, including Data Management Plans (DMPs), Data Validation Plans, and Case Report Forms (CRFs).
• Work with Senior Data Manager to provide regular updates on data status, issues, and progress to internal project teams.
• Communicate with clinical operations team to assess data quality and resolve any data-related issues or concerns.
• Troubleshoot and provide technical support for data-related issues encountered during the trial.
• Proactively identify data-related risks and work with stakeholders to mitigate these risks.
• Ensure proper documentation and tracking of data discrepancies or issues.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Statistics, Computer Science, or related field.
• 2+ years of experience in clinical data management, clinical trial data analysis, or related field within the pharmaceutical, biotechnology, or CRO industry.
• Hands-on experience with EDC systems (e.g., MedNet, Medidata, Veeva Vault), data validation tools, and statistical software (e.g., Python, JMP, SAS, R)
• Familiarity with clinical trial design and regulatory requirements (FDA, EMA, ICH-GCP).
• Experience with data visualization tools such as Power BI.
• Strong analytical and problem-solving skills.
• Excellent communication skills (both verbal and written).
• Ability to collaborate with cross-functional teams and stakeholders.
• Strong attention to detail and ability to work under tight deadlines.
• CDISC (Clinical Data Interchange Standards Consortium) or equivalent certifications are a plus.

Pay

• Base salary $70k-$75k
• Employee Stock Options
• This is a Remote position.
• Medical, Dental, and Vision Insurance
• Health Reimbursement Account (HRA) Flexible Spending (FSA)
• Dependent Care Accounts (DCA)
• Short and Long-Term Disability
• Group Term Life Insurance
• 401(k) with Safe Harbor Match
• Unlimited PTO
• 13 Paid Holidays

Equal Opportunity Employer

MDC is an Equal Opportunity Employer committed to a diverse workforce. MDC will not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, or membership in any other category protected under law.

We invite you to apply if you have an interest in learning more about MDC and joining our mission to provide diagnostic innovators with the exceptional support and personalized solutions they need to make our world a healthier place.