Clinical Research Manager

Clinical Research/Project Manager

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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.

Job Purpose

The Clinical Research/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.

Duties and 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.

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

Working Conditions

• Position will be preferably based at Biolinq Headquarters (non-remote)
• General office, Physician offices, Medical Clinics, Hospitals, and Laboratory
• Travel required up to 50% and will be based on number of clinical studies being conducted
• Hours of work may be outside of the traditional M-F work week

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift/or move up to 15 pounds.

Benefits

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.

At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.

As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $75,000 to $90,000 per year. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.

Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at View email address on click.appcast.io