Job Description

Job Description

Job Description

Overview of Role:

Summit is looking for a creative, resourceful, detail-oriented person who can support clinical data management to ensure completeness, accuracy, integrity and consistency of clinical data and data structure. This person will manage essential study-wide operational tasks that are critical for regulatory compliance and smooth study execution. This role offers a great opportunity to build foundational knowledge in clinical data management and grow within the organization.

The Clinical Data Manager II will support the Clinical Data Management (CDM) team by managing essential study-wide operational tasks that are critical for regulatory compliance and smooth study execution. This role is designed to support the growing portfolio of clinical trials by supporting Lead CDMs in administrative responsibilities and enhancing operational efficiency across multiple studies.

The Clinical Data Manager II will focus on EDC user account management, TMF document filing, and other cross-study administrative activities that require accuracy, consistency, and attention to detail. This role offers a great opportunity to build foundational knowledge in clinical data management and grow within the organization.

Role and Responsibilities:

• Maintain and update EDC user access across multiple clinical studies

• Track and manage user access requests in coordination with CRAs and EDC vendors

• Curate and maintain standardized tracking spreadsheets for both internal and external use

• Transfer verified data from working trackers to production master user lists

• Respond to and resolve user-related queries from study teams and EDC builders

• Prepare and upload CDM documents to the Trial Master File (TMF) in compliance with internal SOPs and TMF standards

• Track document status and ensure completeness and accuracy of TMF content

• Collaborate with Sr. CDMs to ensure documents are audit-ready and filed in a timely manner

• Assist with study startup, maintenance, and closeout CDM activities as needed

• Participate in team meetings, training sessions, and cross-functional collaboration

• Support documentation and version control for CDM tools and templates

• Maintain clear and organized records of work performed

• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience.

• 2+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required

• Ability to perform well-defined procedures initially with supervision, and after direction is provided, work independently

• Ability to work effectively in a team-oriented environment

• Flexibility to adapt to changing project requirements and timelines

• Excellent attention to detail and organizational skills

• Strong communication and collaboration abilities

• Proficiency in Microsoft Excel, Word, and document management tools

• Strong organizational skills to manage multiple tasks and projects simultaneously

• Preferred :

• Experience with EDC systems (e.g., Medidata Rave, Oracle InForm)

• Familiarity with TMF structure and regulatory filing practices

• Understanding of GCP, GCDMP, and clinical trial workflows

The pay range for this role is $103,000 to $121,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

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