- You will manage clinical studies according to applicable regulatory requirements
- Responsible and accountable for oversight and management of CRO(s) and other assigned vendors which may include central and specialty labs, imaging, cardiac safety, and IRT vendors
- Participate in site identification, evaluation, contracting, initiation, monitoring, and close out visits
- Communicate with clinical site staff, investigators, and CROs as appropriate to ensure optimal Sponsor-site relationships
- Support the management of site-related activities, development of tracking tools, and manage recruitment timelines
- Prepare updates on study progress
- Participate in the selection and contracting of third-party vendors
- Prepare study budgets and track payment of contracts related to the project
- Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems
- Participate in EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development, and other related activities
- Monitor clinical data entry progress and follow up with CRO(s) on incomplete data entry and/or outstanding queries
- Anticipate potential study issues and prepare contingency plans with minimal oversight
- Facilitates Clinical Trial Agreements with Legal
- Review and approve all study documents such as essential regulatory packages, ICFs, etc. for accuracy and quality content
- Drive traceability procedures for investigational products and coordinate clinical supply planning with CMC
- Develop study specific documents such as pharmacy manual and informed consent forms
- Trains CRO team members and site staff, as needed
- Responsible for day-to-day management of CRO(s) and other vendors working on assigned study, including setting expectations, training, managing timelines and deliverables, and issue management
- Additional duties and responsibilities as required
- You will have a Bachelors' degree in a health science field preferred, with at least 4 years' experience managing multicenter clinical studies
- Working knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required
- Familiar with Electronic Data Capture Systems
- Ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
- Strong initiative and a can-do attitude, excellent people skills, and a proven record as a team player
- Excellent computer skills (Microsoft Office Word, Excel, PowerPoint, Outlook) required
- Some travel will be required (10-20%)
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Sr. Clinical Trial Manager - Boston, United States - Ikena Oncology Inc
3 weeks ago
Description
About IkenaIkena Oncology (
NASDAQ:
IKNA) is a clinical-stage, targeted oncology company that discovers and develops biomarker-driven therapies for cancer patients who need life-saving treatment by understanding what drives their disease. Ikena is advancing five clinical, preclinical, and discovery programs and has a global strategic collaboration with Bristol Myers Squibb.
Since its inception, Ikena has raised over $300 million from leading life sciences investors and companies that include Atlas Venture, OrbiMed, BMS, Fidelity, Omega Funds, Surveyor Capital (a Citadel company), Invus, Farallon Capital Management, BVF Partners, Cowen Healthcare Investments, Logos Capital, and HealthCor Management.
Ikena priced its IPO in March 2021 and trades on the NASDAQ (Ticker:IKNA).
Ikena Oncology has an exciting opportunity to join the growing clinical organization as a Senior Clinical Trial Manager.
This individual will be responsible for the management of clinical trial activities on one or more of our lead programs.
You will support the clinical team with the implementation and oversight of clinical trials, focusing on the areas of trial planning, enrollment, site monitoring, data quality, and study reporting.
Your Role
