Sr. Clinical Data Manager (Contractor - temp to hire)
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. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.
Summit Activities
We have in-licensed Ivonescimab, which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We plan to initiate phase-III clinical studies in the following NSCLC indications:
Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)
Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)
Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.
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. The Senior Clinical Data Manager of Clinical Data provides solid core and comprehensive data management expertise to provide quality data management deliverables on clinical studies. Responsible for supervising external sub-contractors that perform data management activities as deemed necessary for the conduct of the project. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
Role and Responsibilities:
- Develop and maintain relationships with key stakeholders such as sites staff, CROs, third vendors and study teams.
- Collaborate with Programming, Biostatistics, Clinical Operations, Patient Safety and Pharmacovigilance, Medical Science, and other cross-functional teams to meet project deliverables and timelines.
- Develop and maintain data management plans, data review plans and procedures in accordance with GCP, regulatory requirements, and study-specific protocols.
- Ensure that all data management activities as well as study data is collected, processed, and stored in accordance with study protocol, Good Clinical Practice, and regulatory requirements.
- Design the case report forms (CRFs) in collaboration with the other functional teams according to study protocol and CSDAH.
- Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing. Ensure the eCRFs are properly built and tested through User Acceptance Testing (UAT).
- Serve as the SME in providing guidance to study teams on data management issues, including database design, CRF development, and data cleaning.
- Perform data discrepancies management activities to ensure that data is of high quality and accurate.
- Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews.
- Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews.
- Lead and oversight the database lock activities and ultimate archiving of study data.
- Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors.
- Participate in the training of external vendors and site staff.
- Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met.
- Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
- Support external vendors selection process as needed.
- 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.
- Participates in the protocol development, creates and/or validates all the data management plan documents (CRF, Validation plan, …).
- 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,…).
- 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
- 5 - 7 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
- Strong verbal and written communication skills
- Consistent, detail oriented, communicative, dedicated to do a job well done
- 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.)
- Ready to take over responsibility
- Able to recognize problems and provide solutions
- Excellent organizational skills
- Excellent communicative skills
- Detail oriented
- Independent and proactive way of working
- Team worker