Clinical Data Manager
Bedford, MA
Job Type: Contract | Recruiter: Jaime Gunning | Phone: 617.215.7066
Location: Bedford, MA (Remote)
Length: 12 months
Job Description:
Our client is seeking a skilled and detail-oriented Clinical Data Manager to join their dynamic team. This role is crucial in ensuring the integrity and compliance of clinical data management processes in alignment with regulatory standards. As a key member of the Data Management team, you will play a vital role in supporting clinical trial activities, preparing data for regulatory submissions, and collaborating with various stakeholders to ensure high-quality outcomes. If you are passionate about clinical data management and have a proven track record in the field, we encourage you to apply today!
Essential Duties and Responsibilities (but not limited to):
- Ensure compliance with regulatory standards (i.e., FDA, ICH GCP) and company SOPs throughout data management activities.
- Assist in the preparation of clinical data for regulatory submissions and audits.
- Provide data-related support during clinical trial activities and in interactions with regulatory agencies.
- Maintain detailed documentation of data management activities, including quality control measures and processes.
- Collaborate closely with clinical research teams, biostatisticians, and other stakeholders to support submission preparations and project goals.
- Bachelor's degree in Life Sciences, Data Management, Biostatistics, or relevant field.
- At least 7 years of experience in Data Management, with a focus on submission preparation.
- Proven experience in clinical data management, preferably within a pharmaceutical, biotechnology, or clinical research environment.
- Must have audit preparation experience and legacy studies experience.
- Strong knowledge of regulatory requirements and industry standards for clinical data management.
- A strong analytical and data-driven mindset.
- Excellent attention to detail and organizational skills.
- Strong communication and interpersonal skills, with the ability to work effectively in a team-oriented environment.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
- Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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