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About the Role

Protara Therapeutics is seeking a Clinical Project Manager to support the Clinical Operations (CO) Team with ongoing Protara programs. This role acts as a secondary operational study contact, ensures CRO deliverables are met, and oversees global site selection and activation.

Responsibilities

Serve as the secondary clinical operations contact for one or more clinical trials.
Liaise with other functions to provide study specific required information for Regulatory submissions and Safety reporting.
Work with cross-functional team members during the study conduct phase.
Review bid-defense proposals, assist in CRO selection, LOI, SOW and budget reviews, and timeline development.
Support vendor selection, on-boarding, and management.
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.
Interact with CROs, clinical trial sites, Investigators, Study Coordinators, Pharmacists, and Protara personnel.
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.
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.
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.
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.

Requirements

Bachelor’s degree in clinical research, life science or a related field.
5+ years of relevant clinical trial management experience in the pharmaceutical or biotech industry.
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.
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.
Willingness to travel to clinical research sites, vendors, and New York City office as needed.

Skills

Clinical trial management
ICH
GCP
CFR guidelines
EDC platforms
MS Office Suite
Clinical trial monitoring process
Smartsheet
Prioritization
Attention to detail
Organization
Analytical skills
Problem-solving
Communication skills
Self-starter
Independent work
Meeting deadlines
Interpersonal skills

Location

New York City

Work Type

Temp to Perm
Full-time

Experience Level

5+ years

Education Level

Bachelor’s degree

Salary/Compensations

$68 - $78 per hour

Benefits

Collaborative, open, and fun team-oriented culture
Company-wide dedication to profoundly impacting patients’ lives
Amazing Culture where we live by our core values and behaviors

About the Company

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.
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.

Equal Opportunity

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.