Associate Director, Clinical Data Management

ModeX Therapeutics•Weston, MA

17h

About The Position

The Associate Director of Clinical Data Management is a critical position within the ModeX clinical operations team. This position is responsible for successfully leading the execution of all data management activities, ensuring focus on data integrity, validity, reliability in accordance with standard processes, guidelines, industry best practices and regulatory standards. This position may be involved in process improvement initiatives to support the department and company in achieving objectives and strategic goals. Qualifications ModeX Therapeutics, an OPKO Health company, is the leading clinical-stage biopharmaceutical company developing unique and proprietary-multispecific therapeutics. Its MSTAR platform unites the power of multiple biologics in a single molecule to create multispecific antibodies that bind four or more targets with unprecedented versatility and potency for complex diseases. Its promising first-in-class immunology pipeline includes candidates against immune diseases, including cancer (both solid and hematologic tumors), immune impairment, as well as several of the world's most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is based in Weston, Massachusetts. For more information, please visit www.modextx.com.

Requirements

BA/BS degree required
7-10+ years of experience in clinical research, drug development, or other healthcare environment, including 5+ years of experience in data management
Proven track record of oncology data management excellence with a focus on quality and matrix team environments
Excellent teamwork, communication (verbal and written), organizational, and interpersonal skills
Self-motivated, proactive, and able to prioritize and manage multiple initiatives simultaneously

Nice To Haves

Leadership / mentoring experience is a plus

Responsibilities

Lead all data management activities from study start-up through final database lock for multiple programs
Create and track timelines for Data Management activities
Create and maintain the Data Management Plan
Develop and design Case Report Forms (CRFs)
Develop Database Build specifications
Lead and execute Database Build and testing activities
Define, build, and test edit checks
Perform data review and query generation/resolution
Process/reconcile electronic data received from other data sources, Safety database, labs, etc.
Database lock and transfer process
Track project progress and issue status reports to ensure the achievement of key Data Management milestones, such as database Go-Live and completion of tasks towards Database Lock.
Coordinate the work of CRO staff assigned to the project.
Ensure approved study documentation is maintained and properly stored in the trial master files
Develop or assist with the project training development and delivery, for investigators, clinical sites, project teams and CRO on data collection processes, tools and/or equipment as required
Act as point of escalation for data related issues and queries
Contribute to the continuous improvement of DM and the wider organization through information sharing, training and education
May lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM
May participate in and/or lead DM and cross functional working groups