Clinical Project Manager

Biolinqorporated•San Diego, CA

7d•Onsite

About The Position

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health. The Clinical Project Manager is responsible for completing tasks related to clinical studies in accordance with standard operating procedures, applicable guidance documents and government regulations. This role has no direct reports. The Clinical Project Manager should be able to create and maintain a good and effective working relationship with clinical sites and ensure study compliance with the protocol and all regulatory requirements.

Requirements

Leadership in clinical trial management with in-house personnel, consultants, CRO, cross-functional teams and investigational sites
Bachelor’s (BA or BS) degree in a STEM discipline (Advanced degree desirable) and 5+ years related experience and/or training; or equivalent combination of education and experience.
Degree in Biology, Health Sciences or related field of study is highly desirable.
Extensive knowledge with CTMS, eTMF, EDC, Monitoring & Operational Plans, FDA submission process with IDE, PMA, and 510(k) preferred
Must be independent, self-motivated, highly organized, detail-oriented, multi-tasker, flexible, and collaborative to deliver high quality work

Responsibilities

Create and ensure execution to project plans and timelines for the Clinical Department projects and protocols.
Contribute to the development and continuous improvement of departmental SOPs, work instructions, and quality system documentation as the organization scales.
Track and manage clinical study budgets, purchase orders, and vendor invoices, escalating variances to leadership as needed.
Support negotiation and execution of Clinical Trial Agreements (CTAs), confidentiality agreements, and vendor/CRO contracts.
Maintain oversight of the Trial Master File (TMF) to ensure inspection readiness across all active studies.
Manage clinical study request from inception through Clinical Readiness Review.
Development of study materials (i.e. patient facing, training, monitoring plan, study reports, etc.).
Support selection, qualification, and day-to-day oversight of clinical sites and vendors (e.g., CRO, IRB, EDC, central lab) in a lean, resource-constrained environment for pre-approval and post approval clinical studies.
Assist with clinical device and accessory supply planning and inventory management to support site enrollment needs.
Train clinical study site staff on the use of Clinical and Commercial Devices in accordance with the instructions for use.
Provide clinical study training to site staff pertaining to protocol requirements and good clinical practice.
Manage multiple concurrent studies and competing priorities typical of an early-stage medical device company with lean staffing.
Support risk-based monitoring approaches and help identify, document, and resolve queries and protocol deviations in a timely manner.
Partner cross-functionally with Quality, Regulatory, Engineering, and Marketing to align study timelines with product development milestones.
Assist with the preparation of US and international regulatory submissions for the conduct of clinical studies and the approval of new products.
Participates in regulatory audits from both international and US representatives to support conduct of clinical trials.
Assist with troubleshooting, documenting, and reporting any product or equipment performance issues.
This position assumes and performs other duties as assigned.