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 ApplicationAssistance@vrtx.com
