Location: San Diego, CA
Schedule: Remote and/or Hybrid
Company Overview:
Contineum Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel, oral small-molecule therapies for neuroscience, inflammation, and immunology (NI&I) indications with high unmet needs. We target biological pathways associated with specific clinical disabilities, aiming to impact the course of disease. Our pipeline includes multiple neuroscience-related indications, as well as programs for idiopathic pulmonary fibrosis, and potential other fibrotic disorders.
Job Summary:
The Director of Clinical Data Management will support Clinical Operations and Biometrics to ensure completeness, accuracy, and consistency of clinical data and data structure. This role involves oversight of CRO clinical data management activities, detailed data review, and collaboration with cross-functional teams to meet project deliverables and timelines.
Key Responsibilities:
- Participate in the CRO selection for DM activities (review of proposals, bid defense).
- Provide oversight of CRO clinical data management (CDM) activities for assigned studies.
- Manage URL ownership and user permissions for all clinical studies.
- Review and provide feedback on CDM and study documents, including but not limited to the Data Management Plan, study protocols, data transfer agreements, and data validation specifications.
- Assure 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 review of specification and data validations documents. Review user acceptance testing (UAT) plans and participate in UAT of IRT, EDC, ePRO, eDiary, and other data systems during initial build and subsequent modifications.
- Perform detailed and thorough data review of clinical trial data as needed.
- Represent Clinical Data Management (CDM) at relevant internal and external team meetings.
- Assure timeliness of deliverables (database build, testing, go-live, cleaning, and lock) and manage CRO accordingly.
- Communicate clinical trial status, milestones, and deliverables throughout the duration of the study.
- Contribute to Clinical Data Management Department improvement/enhancement initiatives. Participate in the development and implementation of new technology or tools. Develop core SOPs and templates.
- Supervise clinical data management activities. Perform direct negotiations with the CRO for timelines, processes, and quality issues.
- Provide support for sponsor clinical data medical review.
- Escalate unresolved data or compliance issues to the functional manager(s); work with CRO data managers, partners, vendors, and internal team members for resolution.
- Provide support or assist the Quality Assurance department in conducting audits involving data management activities.
Education and Experience:
- Bachelor’s degree from an accredited institution with a major in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience.
- 10-15+ years of Clinical Data Management experience in biotechnology or pharmaceutical industry with excellent understanding of the clinical drug development processes required. NDA submission experience a plus.
- Thorough knowledge of Medidata RAVE (super user status preferred)
- Thorough knowledge of CDISC standards, SDTM and ADAM datasets
- Consistent, detail-oriented, communicative, dedicated, and accountable. Strong verbal and written communication skills.
- An ability to embrace the importance of teamwork and show strong interpersonal skills and accountability.
- Must have demonstrated ability to be flexible and multitask in fast-paced, high-pressure, changing conditions.
- 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.).
Compensation and Benefits:
We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates who will work in San Diego, CA is $215,000 – $240,000 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits including:
- 90% employer-covered benefits
- Flexible PTO
- A very generous holiday schedule that includes a week off in August and time off around the winter holidays
- A well-stocked kitchen with snacks and beverages
- Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match.
- The comprehensive wellness program includes medical, dental, vision, and LTD coverage.
How to Apply:
Please submit your resume or CV and supporting documents toinfo@contineum-tx.com.
