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Senior Clinical Data Management
3 months ago
Our Mission:
To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, and successful commercialization of patient, physician, caregiver, 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 engage commercialization and/or development partners when appropriate.
We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders.
Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Menlo Park, California, and we have additional offices in Oxford, UK & Cambridge, UK.
Overview of Role:
We are seeking a highly skilled Senior Clinical Data Management (CDM) Contractor with extensive experience in oncology studies, particularly in late-phase trials and regulatory submissions. This role demands hands-on expertise in optimizing data management processes, ensuring data quality, and facilitating seamless collaboration across teams.
Role and Responsibilities:
- Lead the development and refinement of eCRF forms, specifications, and completion guidelines, ensuring alignment with study protocols and regulatory requirements.
- Proactively devise and implement robust edit checks, query logic, and data query resolution strategies to maintain data integrity and quality.
- Take ownership of Serious Adverse Event (SAE) reconciliation between clinical and pharmacovigilance databases, ensuring meticulous consistency and accuracy.
- Design and execute clinical data standards, data management plans, data transfer agreements, and data flow processes, adhering to industry best practices and regulatory standards.
- Manage vendor relationships and promptly resolve data discrepancies to guarantee the availability of complete datasets for analysis.
- Lead data migration processes and oversee database closeout activities, ensuring seamless transitions and compliance with regulatory guidelines.
- Act as a key representative of Data Management in cross-functional meetings, fostering effective collaboration and alignment on data-centric activities and deliverables.
- Provide continuous support and guidance to project teams, anticipating and resolving data-related challenges to ensure project success.
- Advocate for the standardization of data management practices across teams and studies, promoting efficiency and consistency.
- Respond to ad-hoc data requests from clinical teams, assisting in data cleaning, entry, and exploratory analysis as needed.
- Support data review processes by comparing data against protocols, amendments, and study manuals, ensuring adherence to study requirements
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 (oncology experience is required) in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required
- Experience with various data collection and Electronic Data Capture (EDC) systems and understanding of the MedDRA and WHODRUG coding processes
- Excellent interpersonal, communication, and leadership skills
- Consistent, detail oriented, communicative, dedicated to do a job well done
- CRO and vendor oversight experience preferred
- Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
This full-time position contractor will be located at the Menlo Park, CA.
The pay range for this role is at the $71.00 to $76.00 per hour
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 human resources department to obtain prior written authorization before referring any candidates to Summit.
