Company Overview:
Protara Therapeutics is committed to identifying and advancing transformative therapies for people with cancer and rare diseases with limited treatment options. Protara's portfolio includes its lead program, TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer and lymphatic malformations, and IV Choline Chloride, an investigational phospholipid substrate replacement therapy for the treatment of intestinal failure-associated liver disease.
Job Overview:
The Associate Director, Clinical Operations is responsible for supporting the assigned Clinical Program(s) and for ensuring studies (Phase I-IV) within a program are being managed in accordance with Protara's overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials within a Clinical Program comply with Protara's procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. The Associate Director, Clinical Operations is also responsible for the development and implementation of clinical monitoring standards and best practices for effective clinical monitoring of investigational sites in accordance with regulations for identifying and leading strategic and continuous improvement initiatives in monitoring and clinical project management.
- Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Supports program level deliverables/activities at the discretion of the Senior Director, Clinical Operations.
- Accountable for study budgets, timelines, and trial enrollment status with focus on quality.
- Supports the selection, oversight, and management of CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
- Oversees the day-to-day supervision of clinical trial execution, with a focus on site start-up, patient enrollment, monitoring, compliance, data flow from the clinical sites, CROs, and central laboratories.
- Reviews site feasibility/capability assessments in collaboration with the CRO and cross-functional team.
- Reviews and provide clinical operations input into relevant clinical documents such as the protocol, amendments, Case Report Forms (CRFs), IRB/Ethics applications, recruitment materials, and other documents and plans as appropriate.
- Reviews specific study documents e.g., informed consent forms, study reference manuals, operation manuals, training materials.
- Reviews action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
- Attends Clinical Operations and cross-functional project team meetings as well as vendor/CRO operational meetings to ensure compliance with operational standards and procedures.
- Represents Protara externally to Investigators, site staff, and Key Opinion Leaders along with other Clinical Operations personnel.
- Participates in the creation/review/training/maintenance of departmental and organizational SOPs.
- Develops and fosters strong, collaborative relationships with key stakeholders both within and external to Protara.
- Assists with inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct.
- Strives for continuous improvement and more efficient ways of working in Clinical Operations.
Education and/or Experience:
- Bachelor's degree in a scientific discipline or health-related field is required.
- Master's degree in a scientific discipline or health-related field is preferred.
- At least 5-8 years of clinical trial research experience, including on site monitoring experience.
- Minimum of 3-5 years of experience in the management of clinical trials as a project manager or other relevant experience at a pharmaceutical/biotech company or CRO.
- CRO Management experience required.
- Expert knowledge of GCPs, FDA regulations and ICH guidelines required.
- Experience in GCP inspections/audits preferred.
Supervisory Responsibilities: None
Qualifications:
- Therapeutic area experience in Urology and Oncology preferred.
- Experience in Phase I-III clinical studies
- Global experience preferred.
Computer Skills:
- Must be proficient in MS Office Suite with expertise in MS Project or equivalent Project Management software.
- Must be proficient with a Clinical Trial Management System.
Certificates, Licenses, Registrations: None
Other Skills and Abilities:
- Strong ability to prioritize tasks and keen attention to detail.
- Excellent verbal and written communication, and presentation skills.
- Demonstrated leadership and project management skills.
- Proven ability to work on multiple projects in a fast-paced environment.
- Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.
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.
- This position requires travel; the average travel for this position is 20-25% with some variation based upon business needs.
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, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability and veteran status and any other protected characteristics under federal, state or locals laws.