Data Manager

ICON Strategic Solutions; Massachusetts; On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Program

Life assurance

Flexible optional benefits

Job summary

Join a leading global clinical research organization as a Global Data Manager, where you will take charge of data management oversight for clinical trials. This role involves collaborating with diverse teams to establish data management expectations, ensuring the quality and compliance of clinical data, and leading the delivery of critical data management milestones. With a commitment to diversity and inclusion, this innovative firm offers a supportive environment that values high performance and nurtures talent. If you are passionate about making a difference in clinical research, this is the perfect opportunity for you to thrive and grow.

Qualifications

• 5+ years of Data Management experience from start-up to lock.
• Experience managing multiple studies and competing priorities.

Responsibilities

• Lead data management expectations for assigned trials.
• Ensure compliance with regulatory guidelines and documentation.

Skills

Data Management

Clinical Trials Experience

Project Management

Microsoft Office

Leadership

Communication

Education

Bachelor’s degree in Health or Science

Job description

If you are seeking a leadership position in clinical research data management with one of the largest & most reputable global clinical research organizations, please apply to this sponsor aligned position with ICON LLC (global CRO). As a Global Data Manager, you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence. You will provide data management oversight and accountability for one or more clinical trials.

Responsibilities:

1. Takes a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
2. With the trial customer, CRO and other functional partners:
1. Gathers content and integration requirements for eCRF and other data collection tools.
2. Establishes conventions and quality expectations for clinical data.
3. Establishes expectations for dataset content and structure.
4. Sets timelines and follows up regularly to ensure delivery of all Data Management milestones.
3. Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction.
4. Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
5. Ensures real-time inspection readiness of all Data Management deliverables for the trial; participates in Regulatory Agency and internal audits as necessary.
6. Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.
7. Takes a leadership role with the assigned clinical working group(s) to ensure that Data Management and TA trial needs and deliverables are met.
8. Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
9. Presents and trains at investigator and monitor meetings if needed.

Qualifications:

1. Bachelor’s degree or equivalent in Health or Science discipline, with experience in clinical research, desired.
2. Minimum of 5 years of Data Management experience (start-up to lock).
3. Clinical trials experience is required. Experience managing multiple studies at once with experience managing competing priorities is needed.
4. Oncology experience is helpful, but not required.
5. Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional.
6. Project management skills. Must have prior experience creating timelines and managing deliverables.
7. Advanced Microsoft Office skills including the ability to manipulate and analyze data.
8. Very minimal, if any, travel is expected. Possibly for investigator and/or kick-off meetings.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Program, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organization. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.