Associate Director, Clinical Data Management

BioSpace; Weston (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

ModeX Therapeutics, based in Weston, Massachusetts, seeks an Associate Director of Clinical Data Management to lead data management activities across multiple programs with a focus on oncology. You will drive data integrity, planning, CRF design, database builds, and QA in a regulatory environment.

The role requires 7-10+ years in clinical research with 5+ years in data management, excellent teamwork and leadership skills, and onsite collaboration. Onsite 3–4 days per week is expected.

Qualifications

• 7-10+ years of experience in clinical research, drug development, or other healthcare environment.
• 5+ years of experience in data management.
• Proven track record of oncology data management excellence with focus on quality and matrix team environments.

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

Skills

Leadership / mentoring

Teamwork

Communication

Prioritization

Education

BA/BS degree

Job description

Company Overview

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 visitwww.modextx.com.

Company Overview

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 visitwww.modextx.com.

Job Description

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.

Key Responsibilities Include But Are Not Limited To

• 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

Qualifications

• 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
• Leadership / mentoring experience is a plus

Requirement

• Must be onsite 3–4 days per week.

ModeX Therapeutics is an Equal Opportunity Employer