Job Description
General Summary:
Leads cross-functional CDM study teams and coordinates CDM activities within multiple studies. As an experienced professional with broad knowledge of all areas of CDM processes and systems, provides operational input, technical guidance, and hands-on support to study teams in the design, documentation, testing, and deployment of Electronic Data Capture (EDC) systems and all external clinical data systems. Collaborates with program leaders and business units to understand operational obstacles and needs, ensuring that EDC and external data systems meet the needs of the trial, the users, and the company effectively.
Key Duties and Responsibilities:
Defines and manages CDM project timelines on multiple complex studies or programs
Responsible for all assigned CDM study deliverables, evaluates and mitigates risks across program/s
Responsible for study and/or program resource planning
Assists in establishing CDM vendor management strategies for a program
Reviews and provides input to vendor RFIs, RFPs, proposals and contracts
Provides recommendations for and implements new technologies resulting in process improvements
Participates in and may lead cross-functional process initiatives
Actively identifies risks, develops risk mitigation plans, and executes plans
Reports progress, status, risks, timelines, and needs to stakeholders
Leads continuous improvement process, including:
ensuring underlying processes, workflows, documentation and technologies effectively support intended system functionality, reporting, and study needs in a streamlined manner
creating and updating SOPs, work instructions, and training materials
setting and maintaining system standards to ensure optimal study execution
Serves as a process/program owner in assigned area
Leads cross-functional discussions of external data transfers and integration with clinical systems (e.g., EDC, IXRS, CTMS)
May supervise other staff
Knowledge and Skills:
Proven ability to independently determine the most appropriate methods and procedures across Clinical Data Management projects
Advanced writing and verbal presentation skills, with the ability to convey complex/technical findings to varied audiences and build alignment around a topic/issue
Advanced knowledge of CDM and all relevant disciplines related to the drug development process
Ability to conceptualize customized EDC functionality and provide input to vendor on design
Strong experience with technical specifications, with an ability to translate them into nontechnical terms
Strong knowledge of software development and testing methodologies (SDLC)
Ability to manage multiple projects at various stages in the lifecycle
Strong leadership, decision-making and problem-solving skills required
Strong verbal/written communication, presentation skills and interpersonal skills
Proficient in MS Office applications including Microsoft Project and Sharepoint
Strong understanding of clinical operations workflows
Knowledge of database development methodologies
Education and Experience:
Bachelor's Degree in a scientific or allied health field (or equivalent degree)
Typically requires significant, relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent combination of education and experience
Flex Designation:
Remote-Eligible
Flex Eligibility Status:
In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Remote
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at
[email protected]