Clinical Project Manager, Temp to Perm

Protara Therapeutics, Inc.; Oregon; Hybrid; USD 94.000 - 107.000; Vollzeit

Zusammenfassung

Protara Therapeutics, Inc. is seeking a Clinical Project Manager, Temp to Perm, to support the Clinical Operations team across ongoing programs.

The role involves coordinating CROs, regulatory submissions, safety reporting, and site monitoring with a focus on ensuring inspection readiness and smooth study execution. Qualifications include a bachelor's degree in clinical research or life sciences and at least 5 years of trial management experience, with familiarity in ICH/GCP/CFR guidelines and

Qualifikationen

• Bachelor's degree in clinical research, life science or related field.
• 5+ years of relevant clinical trial management experience in pharma/biotech.
• Knowledge of ICH, GCP and CFR guidelines.

Aufgaben

• Serve as secondary clinical operations contact for one or more trials.
• Liaise with Regulatory for submissions and safety reporting.
• Support CRO selection, LOI, SOW and budget reviews.
• Manage study eTMF and inspection readiness.
• Oversee financials: CRO invoicing, budgets and invoices.
• Interact with CROs, sites, investigators, coordinators, pharmacists, and Protara staff.
• Travel to clinical sites as needed (up to 30%).

Kenntnisse

ICH/GCP/CFR knowledge

EDC platforms experience

MS Office proficiency

Clinical trial monitoring knowledge

Smartsheets familiarity

Ausbildung

Bachelor's degree in clinical research or life sciences

Tools

Smartsheets

EDC platforms

Jobbeschreibung

The Clinical Project Manager, Temp to Perm, is responsible for supporting the Clinical Operations (CO) Team with all ongoing Protara programs as requested.

Company Overview:

Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara's portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes. Protara was named one of the Best Places to Work by BioSpace , a leading industry news and job source. This honor demonstrates the company's desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation. Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.

Job Overview:

Essential Duties and Responsibilities include the following (Other duties may be assigned):

• Serve as the secondary clinical operations contact for one or more clinical trials, as needed.
• Liaise with other functions to provide study specific required information for Regulatory submissions, Safety reporting (e.g. DSUR submissions to IRBs, Safety Vigilance portal access, etc.).
• Work with other cross-functional team members during the study conduct phase.
• Review various bid-defense proposals, assist in CRO selection, LOI, SOW and budget reviews. and timeline development.
• Support vendor selection, on-boarding, and management throughout the life cycle of the study.
• Serve as the Manager of the study specific eTMF and related activities to ensure inspection readiness compliance.
• Assist with the management of the financial aspects of clinical trials (e.g., ensuring that CROs are invoicing Protara correctly according to Fully Executed contracts and reviewing monthly work completed workbooks, reviewing site budgets and invoices).
• Interact with CROs, clinical trial sites, Investigators, Study Coordinators, Pharmacists, and Protara personnel as appropriate.
• Serve as a resource for internal/external teams and investigational sites.
• Remotely monitor EDC data on a pre-determined basis for any expected interim data cuts.
• Review clinical protocols, amendments, informed consents, CRF/ source document design, monitoring plan, site instruction manuals, protocol specific training documentation, oversight plans and other project related documents, as applicable.
• Assist with global clinical trial sites identification, selection, activation, and participation.
• Assist in the review of Pre-Study Site, Site Initiation, Interim, and Close-Out visit reports within specified time frames, as applicable.
• Oversee the tracking of study recruitment/enrollment, trial specific reports, and documents necessary for clinical trial completion.
• Perform internal oversight of CTMs/CRAs performing site monitoring visits.
• Serve as the primary point of contact for internal CTMs and CRAs.
• Proactively manage/identify potential study issues/risks and recommend/ implement solutions with key internal/external stakeholders.
• Prepare metrics and updates for senior management.
• Mentor junior staff and perform additional duties or functions as required.
• Contribute to wider organizational goals and/or activities as assigned.
• Willingness to travel to clinical research sites to perform CRO clinical monitoring oversight (as needed).

Education:

• Bachelor's degree in clinical research, life science or a related field is required.
• 5+ years of relevant clinical trial management experience in the pharmaceutical or biotech industry required.

Supervisory Responsibilities:

No

Qualifications:

• Knowledge of ICH, GCP, and CFR guidelines.
• Prior experience with different EDC platforms.
• Proficient in MS Office Suite.
• Knowledge of the clinical trial monitoring process.
• Knowledge of Smartsheets preferred.

Other Skills and Abilities:

• Strong ability to prioritize tasks with keen attention to detail.
• Strong organizational, analytical, problem-solving, and communication skills.
• Must be a dependable self-starter and capable of working independently with the ability to prioritize tasks and meet deadlines.
• Thrives in a small biotech, fast-paced environment.
• Strong interpersonal skills with the ability to interact effectively with all levels of management, both internal and external to the organization.

Compensation:

Hourly Rate Requirements are between $68 - $78 based on experience and qualifications.

Why You'll Love Working at Protara

• Collaborative, open, and fun team-oriented culture that values multiple perspectives.
• Company-wide dedication to profoundly impacting patients' lives.
• Amazing Culture where we live by our core values and behaviors.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Average travel for this position is 30% with some variations based on the demands of business needs.
• Must be willing to travel to clinical trial sites, vendors as applicable, and New York City office as needed.

Work Environment:

No specific work demands.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws.