Massachusetts Veterans Jobs

Job Title: Associate Director, Clinical Data Management

Job Description

We are seeking an experienced Associate Director of Clinical Data Management to define and lead our data management strategy. This pivotal role will oversee the start-up and execution of multiple, complex trials in collaboration with a Contract Research Organization, while supporting upcoming submissions. As a key figure in our data management team, you will be responsible for coordinating and managing daily data management and vendor oversight activities across multiple clinical trials. This role is a blend of hands-on work and vendor management, wherein you will be one of two data managers handling a Phase III study this year, with two additional studies planned for 2025.

Qualifications

• Requires a Bachelor’s degree within a scientific discipline (advanced degree a plus) with a minimum of 10+ years of experience within biotech/biopharma and/or CRO organization

• Hands on Vendor Management experience

• Extensive knowledge and experience in clinical data management

• Direct experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards

• Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans

• Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG)

• Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations

• Demonstrated experience in managing multiple CROs/vendors

• Demonstrated strong written and verbal communication skills

• Proven mindset of proactive continuous improvement

• Efficient independent worker with ability to focus and drive for results

• Strong attention to detail

• Ability to work in a fast paced-environment and to handle multiple tasks

• Strong commitment to ethical standards

• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)

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 & Inclusion

At 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 people

The 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.