Director, Data Management

Imperatrix Datum Solutions Corporation; United States; On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Director of Data Management to lead a dynamic team focused on optimizing data management processes in clinical trials. This role involves overseeing staff, managing multiple projects, and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in data management within the medical or pharmaceutical industries and a passion for improving patient outcomes through innovative imaging solutions. Join a collaborative environment where your expertise will directly contribute to advancing cancer research and enhancing the lives of patients worldwide.

Qualifications

• 8-10 years of direct data management experience required.
• 5+ years of line management experience in a regulated environment.

Responsibilities

• Manage data management staff and oversee project deliverables.
• Develop and track timelines to ensure milestones are met.
• Collaborate with teams to develop documentation for studies.

Skills

Data Management

Clinical Research

MS Office

Electronic Data Capture Systems

Communication Skills

Regulatory Guidelines

Project Management

Detail-oriented

Education

Bachelor’s degree in a science related field

Tools

Excel

SAS

SPSS

iMednet

Medidata

Oracle Clinical RDC

Job description

SUMMARY

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

The primary responsibility of the Director, Data Management is to manage the DM department staff and support the DM Department Head in all aspects of the data management process through the life cycle of each project.

RESPONSIBILITIES

• Responsible for all aspects of data management and deliverables across multiple study projects.
• Manage and oversee day-to-day activities of data management staff and provide training and guidance.
• Provide line management to data management staff.
• Report status of data management activities to Executive Management.
• Provide input to executive management in the development and budgeting of data management line items in proposals.
• Travel to and participate in due diligence and/or bid defense activities.
• Author DM SOPs as needed.
• Act as the primary interface and collaborate with Imaging Operations, Scientific Affairs and Clinical Research to develop all DM documentation and activities for Study Startup, Conduct and.
• Provide clinical and image data management support to the operations team. Support DM leads in their work and reporting to Project Managers (PMs) such DM work is prioritized and accomplished per Company directives.
• Develop and track timelines to ensure data management milestones are met in coordination with the project team.
• Direct and/or author Data Management Plans and maintain them throughout the lifecycle of a project.
• Direct and/or author data management study documentation; for example, edit check specifications, eCRF and database requirements, data QC processes, CRF completion guidelines, data transfer plans, data import plans.
• Develop documentation for UAT of EDC Systems.
• Oversee and/or participate in the execution of UAT.
• Train End-users on data collection tools.
• Lead and/or participate in data cleaning procedures; including issuing & closing queries, presenting tables & listings review.
• Quality review of visual and tabular representations of data in a variety of MS Office products.
• Participate in conference calls, sponsor visits and audits (internal and external) as needed.
• Able to manage multiple projects with shifting priorities within a small company environment.
• Perform other duties as assigned.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in a science related field.
• Minimum of 8-10 years of direct data management experience.
• 5+ years of line management experience in a regulated environment within the medical device, biotechnology, or pharmaceutical industries.
• Exposure to medical imaging considered a plus.
• Working knowledge of Good Clinical Practices, clinical research, clinical trials and related regulatory requirements, industry best practices and terminology.
• Vendor management experience a plus.
• Exposure to the principles of CDISC considered a plus.

SKILLS

• Strong working knowledge of the regulations governing the development of electronic data capture systems.
• Working knowledge of mainstream data management platforms, such as Excel, SAS, SPSS, iMednet, Medidata, Oracle Clinical RDC.
• Strong working knowledge of MS Office.
• Demonstrated proficiency initiating and managing clinical data management projects.
• Ability to interpret and apply regulatory guidelines and requirements within procedures.
• Process-minded individual that constantly strives for perfection.
• Proven ability to function in a complex business and compliance environment.
• Flexible; able to quickly shift gears and respond to changing organizational goals and needs.
• Understands the use and utility of medical imaging in clinical trials.
• Understands complex clinical research protocols.
• Ability to communicate effectively one-to-one, in small groups and in public speaking contexts; effective writing as evidenced by precise, well-organized emails, letters and proposals while using appropriate tone, vocabulary and grammar.
• Ability to organize and schedule resources in an efficient manner while anticipating contingencies and paying careful attention to detail.
• Self-motivated with ability to work under minimal supervision and aggressive timelines.

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

• Passion to Connect Imaging to the Cure^TM and pursue a meaningful career by improving the lives of cancer patients through imaging.
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging.
• Commitment and caring for our fellow team members, their families, and the communities IE serves – see more information about Caring Endpoints at Caring Endpoints.
• Integrity and high ethical standards; we always do the right thing.
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives.
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE.
• Accountable; we do what we say and communicate effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success.
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else.

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use arms, hands, and fingers to handle, feel or reach, and to talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: Approximately 20%