Director of Clinical Data Management
The Director of Clinical Data Management is a newly created, high impact role reporting to the Chief Product Development Officer.
As the primary thought leader for data management, you will be responsible for the department’s overall strategy, oversight of vendors, FDA compliance, internal representation, and future growth.
This highly visible position will play an important role in achieving Constellation’s objectives by producing high-quality data to inform executive leadership decisions and critical professional presentations and by ensuring optimal user experience of clinical sites through appropriate database configuration. We are #BrighterTogether.
How you will spend your day:
- Accountable for the implementation study data strategies and overall (data-related) project management
- Provide leadership for data management, coding, data systems, and data quality/integrity
- Oversee all data management activities performed by CROs and apply your experience in the design and management of clinical trial databases
- Ensure the proper collection, management, and storage of clinical trial data (according to regulatory requirements)
- You will oversee and participate in study set-up and initiation procedures such as CRF design, database design, edit check design/review, and DMP (data management plan) review
- Assist in developing data management guidelines and quality processes to ensure final databases are accurate
- Routinely summarize data (in high quality tabular, graphics, and listing format) for use in both professional presentations and general business use
- Work closely on-site with Clinical Operations, Biostatistics and other members of the Development Team, as well as outside vendors/CROs
- Represent the Data Management internally and may function as a representative on project teams, study teams, and development teams
- Communicate requirements, strategy, timelines, and deliverables at internal cross-functional meetings and meetings with external vendors.
Key things about you:
- Bachelor’s degree in scientific, biological, statistical, computer science, or related field
- 7+ years of clinical trial data management experience under your belt
- A natural leader, you will have either gained experience directly managing teams or mentoring indirect reports
- An expert in managing EDC Databases and proficient in Microsoft Office
- Familiar with ICH GCP and have a general knowledge of industry practices and standards such as CDISC-SDTM data standardization specifications
- Ideally have experience working with safety data and coding dictionaries (MedDRA and WHODD)
- Experience with the collection of Patient-Reported-Outcomes (via tablet, etc.) preferred
- You will have a flair for presenting data in clear and meaningful ways
Constellation Pharmaceuticals is an Equal Opportunity Employer, a participant in E-Verify and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.