Senior Manager, Clinical Data Management

Summit Therapeutics Plc • Menlo Park, CA

305d • $163,000 - $191,000

About The Position

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. The role involves providing oversight to CRO clinical data management (CDM) activities for assigned studies, reviewing and providing feedback to CDM and study documents, and ensuring that case report forms (CRFs) are designed and developed in accordance with study protocol and other supporting documentation. The position also requires overseeing the electronic data capture (EDC) database build process, performing detailed data reviews, and representing the CDM team at cross-functional meetings.

Requirements

• 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
• Strong track record of line management and supervisory experience of CDM staff
• 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.)

Nice To Haves

• Phase 3 Oncology clinical trials experiences highly desired

Responsibilities

• Provide oversight to CRO clinical data management (CDM) activities for assigned studies
• Review and provide feedback to CDM and study documents, including Data Management Plan, study protocols, data transfer agreements, and data validation specifications
• Ensure case report forms (CRFs) are designed and developed in accordance with study protocol and supporting documentation
• Oversee electronic data capture (EDC) database build process, including review of specification and data validations documents and user acceptance testing (UAT)
• 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 manage CRO accordingly
• Communicate clinical trial status, milestones, and deliverables throughout the study duration
• 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
• Serve as the primary point of contact for partners and sub-contractors on data management deliverables and activities
• Provide data management and technical expertise while working with CRO data managers and key decision-makers for end-to-end DM activities
• Supervise clinical data management activities and perform direct negotiations with the CRO for timelines, processes, and quality issues
• Identify requirements for the development and amendments of the clinical database in cooperation with the trial team
• Validate or perform sponsor User Acceptance Testing of a clinical database
• Provide support for sponsor clinical data medical review
• Escalate unresolved data or compliance issues to functional manager(s) and work with CRO data managers, partners, vendors, and internal team members for resolution
• Participate in the development and implementation of new technology or tool
• Participate in the CRO selection for DM activities
• Provide support and review the Scope of Work / Contracts and budgets for data management activities
• Review invoices for data management activities as necessary
• Provide input on developing, revising, and maintaining core operating procedures and templates
• Support or assist the Quality assurance department in conducting audits involving data management activities

Benefits

• The pay range for this role is $163,000 - $191,000 annually
• Total compensation package may include bonus, stock, benefits and/or other applicable variable compensation

What This Job Offers

• Career Level: Senior
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree