Director, Clinical Data Management
The Director, 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.
How you will spend your day:
- You will be accountable for the implementation study data strategies and overall (data-related) project management
- You will provide leadership for data management, coding, data systems, and data quality/integrity
- You will oversee all data management activities performed by CROs and apply your experience in the design and management of clinical trial databases
- You will 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
- You will regularly summarize data (in high quality tabular, graphics, and listing format) for use in both professional presentations and general business use
- You will work closely on-site with Clinical Operations, Biostatistics and other members of the Development Team, as well as outside vendors/CROs
- You will represent 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:
- You will offer a 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.
- You will be an expert in managing EDC Databases and proficient in Microsoft Office
- You will be familiar with ICH GCP and have a general knowledge of industry practices and standards such as CDISC-SDTM data standardization specifications
- You will also 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.