Clinical Trial Manager

ABOUT NOVEOME BIOTHERAPEUTICS, INC.

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Noveome Biotherapeutics, Inc. is a dynamic clinical-stage biopharmaceutical company with an innovative platform technology that represents a paradigm shift in drug development. Unlike most drugs that are single molecules directed at specific indications, Noveome's product is a complex mixture of biomolecules that is believed to have the ability to treat a wide range of conditions and injuries. Noveome collaborates with major research centers to advance these therapeutic applications.

POSITION OBJECTIVE

This Clinical Trial Manager (CTM) – Senior CTM is responsible for managing the clinical trial process via daily engagement with the CRO, ensuring compliance with Good Clinical Practice (GCP), International Conference of Harmonization (ICH), Code of Federal Regulations (CFR), and standard operating procedures (SOPs). The position focuses on clinical study conduct and ensuring that daily operational activities are running efficiently at each trial site, including establishing and maintaining routine clinical site engagement and CRO study team oversight, ensuring project goals, including timeline and milestones are met. Creatively engaging with CRO and trial site research teams to develop novel approached to enrollment barriers.

WHAT YOU WILL DO FOR NOVEOME

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Collaborates with CROs, vendors, and clinical research teams (site and CRO inclusive) to ensure compliance with processes and regulatory guidelines. Ensures that clinical milestones are completed for invoiced items.

• Monitors and tracks progress and obstacles during clinical trial, works with Noveome Clinical Ops team to respond to daily issues, anticipates and shares with Noveome Clinical Ops team potential study issues as well as presents creatively prepared solution options and/or contingency plans for consideration including identifying risks/benefits of said options/contingency plans, which are then presented to the CRO for consideration and execution upon alignment.

• Communicates with clinical trial sites to ensure optimal Sponsor-Site relationships.

• Oversees study specific timelines. Reviews regular status reports of study progress and metrics. Presents results to management.

• Reviews process of case report forms to ensure consistency between protocol and database, and participates in protocol deviation review in collaboration with CRO.

• Collaborates with CRO to develop, review and present newsletters, site communications, and Qualification Visit and Site Initiation Visit, as well as Town Hall, presentations.

• Collaborates with CRO to ensure the set-up, maintenance, reconciliation, and archiving of electronic and paper TMFs along with internal working files is appropriate performed. Coordinates TMF transfer with Clinical Research Organizations (CROs). Performs periodic quality assessments of clinical TMF documents.

• Supports the development and implementation of SOPs and common departmental work practices.

• Collaborates with the CRO to ensure the monitoring visit schedule with available reports are completed as expected per contracted requirements. Conducts first-pass reconciliation of pass-through invoiced work.

• Coordinates with CRO/CRAs to conduct periodic on-site monitoring, co-monitoring, training, audits, or motivational site visits as necessary.

• Coordinates other CRO engagements as warranted regarding site-specific barriers to enrollment, such as engagement with transfer sites regarding early awareness of study participation opportunities.

Please note, as a company rooted in innovation our positions are consistently evolving and we champion the development of all roles. This job description is not designed to contain comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.

REQUIRED QUALIFICATIONS

• Knowledge of FDA requirements

• Knowledge of essential regulatory documents

• Knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines

• Knowledge of applicable regulatory guidelines • Inspection readiness (TMF compliance) experience

• Clinical Trial Study Start Up Institutional Review Board (IRB) experience

• Clinical Study Implementation/trial management experience

• Document Management

• Medical Terminology

• Phase 1-3 clinical trial experience

• Pediatric-Specific Regulations: Training on FDA and EMA pediatric research requirements, Written Requests, Pediatric Investigation Plans (PIPs), and ethical frameworks like the Declaration of Helsinki provisions for minors.

• Consent and Assent Dynamics: Operational training on how to communicate clinical concepts clearly based on different developmental age groups and document assent properly.

• Tenacity and active engagement to ensure operational success across all study activities.

BENEFICIAL QUALIFICATIONS

• Basic statistical knowledge

• Drug development knowledge

• Site monitoring experience and/or thorough knowledge of monitoring process

ATTRIBUTES OF SUCCESS

Analytical thinking Adaptability Collaborative Tenacious Interactive Communication

Detail oriented Self-motivated Persuasive Accountable Problem Solving

WORK ENVIRONMENT/PHYSICAL DEMANDS

Subject to extended periods of sitting and/or standing, vision to monitor and typing. Work is generally performed in a temperature-controlled office/home office environment.

REGULAR SCHEDULE

This is a salaried exempt full-time position with potential 7 days/non-routine on occasion for cross-coverage with CMO, Clinical Operations, and CRO to complete to support study enrollment activities. Travel as required.

WHAT NOVEOME WILL DO FOR YOU

Noveome provides transparency in expectations, encourages innovative thinking, opportunities for expanded learning, competitive salaries, and a clean safe work environment. Eligible employees will appreciate the comprehensive benefits package and wellness perks.

LOCATION PITTSBURGH OR REMOTE

REPORTS TO SR. DIRECTOR OF CLINICAL OPERATIONS WITH SOME OVERSIGHT FROM CMO

EDUCATION REQUIREMENTS BACHELOR'S DEGREE WITH 5+ YEARS' EXPERIENCE PHARMACEUTICAL OR DEVICE INDUSTRY OR DRUG DEVELOPMENT EXPERIENCE

RELATED DEGREE PROGRAMS SCIENTIFIC - BIOLOGY, BIOCHEMISTRY, HEALTHCARE – NURSING CLINICAL – CLINICAL RESEARCH MANAGEMENT

BENEFICIAL CERTIFICATIONS CERTIFIED CLINICAL RESEARCH ASSOCIATE (CCRA),

CERTIFIED CLINICAL RESEARCH PROFESSIONAL (CCRP)

ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS – CERTIFIED PROF (ACRP-CP) ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS – PROJECT MGR (ACRP-PM)

A combination of experience and/or education will be taken into consideration. xhyhwjd

Noveome is an Equal Opportunity Employer.