Clinical Data Manager II
Clinical Data Manager II
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$ 103000 - 121000
1 Vacancy
Job Description
Overview of Role:
Summit is looking for a creative resourceful detailoriented 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 studywide operational tasks that are critical for regulatory compliance and smooth study . 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 studywide operational tasks that are critical for regulatory compliance and smooth study . 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 crossstudy 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 userrelated 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 auditready and filed in a timely manner
Assist with study startup maintenance and closeout CDM activities as needed
Participate in team meetings training sessions and crossfunctional 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:
Bachelors 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 welldefined procedures initially with supervision and after direction is provided work independently
Ability to work effectively in a teamoriented 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 $103000 to $121000 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 Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Manager
Employment Type
Full-Time
