Job Title: Senior Manager, Clinical Data Management

Department: Clinical Data Science

Location: Remote US

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and to pursue commercialization and/or development partners when and where appropriate.

We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission. Team Summit exists to strategize and execute a path forward in medicinal therapeutic health care that places us in a top market share leadership position. Team Summit assumes responsibility for stimulating continuous expansion of knowledge, ability, capability and wealth for all involved stakeholders.

Overview of Role:

Summit is looking for a creative, resourceful, detail-oriented person who can support clinical data management to ensure completeness, accuracy and consistency of clinical data and data structure.

Role and Responsibilities:

• Provide oversight to CRO clinical data management (CDM) activities for assigned studies
• Review and provide feedback to CDM and study documents, including but not limited to the Data Management Plan, study protocols, data transfer agreements and data validation specifications
• Responsible for assuring case report forms (CRFs) are designed and developed in accordance with study protocol and other supporting documentation
• Oversee electronic data capture (EDC) database build process, including but not limited to review of specification and data validations documents and user acceptance testing (UAT) of the EDC during initial build and subsequent database modification
• Perform detailed and thorough data review of clinical trial data when necessary
• Represent the Clinical Data Management (CDM) team at cross-functional and clinical study team meetings
• Assure timeliness of deliverables and managing CRO accordingly
• Communicate clinical trial status, milestones, and deliverables throughout duration of study
• Collaborate with Programming, Biostatistics, Clinical Operations, Patient Safety and Pharmacovigilance, Medical Science, and other cross-functional teams to meet project deliverables and timelines
• Support external vendors selection process as needed
• Contribute to Clinical Data Management Department improvement/enhancement initiatives
• Serves as the primary point of contact for partners and sub-contractors on data management deliverables and activities.
  • Provides data management and technical expertise while working with CRO data managers and key decision-makers for end-to-end DM activities.
  • Supervises clinical data management activities. Performs direct negotiations with the CRO for timelines, processes, and quality issues.
  • Identifies the requirements for the development and amendments of the clinical database in cooperation with the trial team (Managers Clinical Trial, Medical / Clinical Development experts,…).
  • Validates or performs sponsor User Acceptance Testing of a clinical database.
  • Provides support for sponsor clinical data medical review.
  • Escalates unresolved data or compliance issues to the functional manager(s); works with CRO data managers, partners, vendors, and internal team members for resolution.
  • Participates in the development and implementation of new technology or tool.
  • Participates in the CRO selection for DM activities (review of proposals, bid defense).
  • Provides support and reviews the Scope of Work / Contracts and budgets for data management activities. Reviews invoices for data management activities as necessary.
  • Provides input on developing, revising, and maintaining core operating procedures and templates.
  • Provides support or assists the Quality assurance department in conducting audits involving data management activities.

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
• 8+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required. Phase 3 Oncology clinical trials experiences highly desired.
• Strong track record of line management and supervisory experience of CDM staff, shown leadership skills to lead and inspire CDM staff including consultants.
• Consistent, detail oriented, communicative, dedicated and accountable. Strong verbal and written communication skills
• CRO and vendor oversight experience preferred
• Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

The pay range for this role is $163,000 – $191,000 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.