Company Overview:
Protara Therapeutics is a clinical-stage biotechnology companycommitted 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:
The Clinical Project Manager, Temp to Perm, is responsible for supporting the Clinical Operations (CO) Team with all ongoing Protara programs as requested. Activities will include but are not limited to, acts as the secondary operational study contact for internal and external stakeholders, ensures Contract Research Organizations (CROs) are meeting their project deliverables within the agreed upon timelines, serves as the primary contact for Clinical Trial Manager(s) (CTMs) and Clinical Research Associates (CRAs), performs internal oversight of CTMs/CRAs performing CRO oversight monitoring visits, oversees global site selection and activation, reviews site budgets and contracts, supports document collection for RA/IRB submissions, implements recruitment strategies to meet enrollment objectives, oversees trial eTMFs, and tracks CRO’s Standard Operating Procedures (SOPs) for each trial.
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…