Ocera Therapeutics is always interested in meeting excellent candidates with experience relevant to any part of our organization. Our company offers a package of competitive compensation and benefits.
Palo Alto, CA
We do not currently have any open positions at the Palo Alto site.
Research Triangle Park, NC
POSITION: CLINICAL PROJECT MANAGER
Reporting to the Senior Director, Clinical Operations, the Clinical Project Manager will have the following primary responsibilites.
- Schedules, coordinates, supervises, and delivers services to clients to fulfill contract obligations in accordance with the Task Order, FDA regulations, ICH guidelines and SOPs.
- Manages project timelines through all study phases, from startup through closeout.
- Ensures that projects are conducted on-time and within budget; meets quality standards and expectations outlined.
- Develops and implements the Project Management Plan within the scope of the contract, clinical protocol, applicable SOPs, and The Company’ standard processes; ensures cross-functional team also adheres to the same standards.
- Oversees, reviews, and is accountable for all deliverables produced by the study team.
- Manages all contractual and financial aspects of the project, including finalization of initial task order and subsequent amendments, monthly budget review including forecasting and assessment of work performed, and appropriate client invoicing and site/vendor payments.
- Provides overall guidance, motivation, and mentoring to project team members, including training plans as appropriate.
- Delegates, as appropriate, tasks to team members, including Clinical Trial Lead (CTL), Clinical Research Associate (CRA,) and In-house CRA levels while maintaining responsibility for team output.
- Creates and maintains study quality plans consisting of regular review of study, site and staff performance metrics.
- Assesses and communicates resourcing needs to the Clinical Operations Director.
- Manages vendor relationship to assure satisfaction.
- Serves as the primary project contact for communication and coordination for sponsor, CRO, and any other project stakeholders.
- Escalates study and team issues to Clinical Operations Director.
- Creates, edits, reviews, and/or contributes to the creation protocols and other study materials.
- BS/BA degree, preferably in a scientific or health-related field; or equivalent experience
- Progressive experience in the management and conduct of clinical research including ICH-GCP requirements, drug or device development process, budgeting and forecasting, regulatory compliance, project management, study coordination, leading project teams in a matrix environment, etc.
- Strong computer skills, including a solid understanding of Microsoft Office Suite. Demonstrated ability to learn other applications
- Experience supervising or managing professional staff in a clinical research environment
- Demonstrated negotiation skills and ability to gain the cooperation of others
- Excellent written/verbal communication and presentation skills, and the demonstrated ability to review deliverables to confirm accuracy and professional presentation
- Demonstrated ability to meet timelines and report study progress to upper management
- Working knowledge of medical terminology, FDA regulations and ICH guidelines
- Read, write and speak fluent English
- Ability to travel a minimum of 5%
POSITION: VICE PRESIDENT, CLINICAL OPERATIONS
Reporting to the Chief Medical and Development Officer, the Vice President of Clinical Operations will have primary responsibility for overseeing the conduct of the clinical trials for the company’s drug candidates. Serve as company clinical expert in investigator, medical advisory and regulatory meetings. Contribute to the set-up of clinical studies, including creating protocols, case report forms, investigator brochures and other study start-up documents. Provide daily guidance to the clinical operations team and take ownership of the interaction with Quintiles for HE209.
- Oversee the conduct of HE209
- Work with clinical investigators to execute clinical programs/studies according to GCP
- Orchestrate meetings to determine best clinical path forward for a clinical program
- Develop study outlines, protocols, amendments and investigator brochures
- Work with statistics to plan data analysis
- Interpret, analyze, and write/produce clinical research medical reports and other documents
- Author briefing booklets, contribute to drug safety board charters, clinical sections of regulatory submissions and presentation slide data for internal and investor use
- Partner with department managers to trouble shoot study protocol issues as they arise and provide clinical response to questions from investigators, site coordinators, health authorities and institutional review boards
- Author draft scientific publications from clinical study data and on investigational products or safety questions
- Review clinical SOPs and contribute to clinical department process improvements
- Participate in meetings with FDA or other regulators and work with the VP, Regulatory Affairs on the documentation submission process to regulators
- Conduct, participate in and provide status updates to internal project teams to ensure development strategies are continually valid and on track
- Oversee serious adverse event process; coding/medication/patient history
- Medical Degree and board certification with a minimum of ten years of relevant experience in clinical research, preferably in the areas of critical care and/or hepatology
- Proven successful management of teams and projects
- Superior verbal and written communication skills with specific proven expertise in medical writing, including protocol development, clinical sections for regulatory filings and investigator brochures
- Ability to maintain, translate and apply high-level basic science, technical, medical, and clinical knowledge and information
- Ability to work in a small company, fast-paced dynamic environment and maintain a high degree of flexibility
- Goal-oriented, attentive to detail, ability to work in an interdependent team
- Hard-working multi-tasker, self-reliant, energetic and passionate
- Strong computer proficiency including standard office programs
In keeping with Ocera's commitment to its employees, we currently offer a comprehensive and generous employee benefits package which includes medical, dental, vision, life, short and long-term disability, flex-spending and 401(k) plans, along with paid holidays and a paid time off program.
Resumes may be submitted to: email@example.com