Clinical Project Manager
Clinical Project Manager
WEST HOLLYWOOD CA US 90069-3704
ONCOtherapeutics is a full-service Contract Research Organization (CRO) with a unique focus in the therapeutic area of oncology. We are a strategic CRO running multiple clinical trials in community oncology sites throughout the United States (US). We provide necessary support to major biopharmaceutical companies throughout the US to successfully run, enroll and completion of clinical trials. Uniquely focused on community-based Hematology & Oncology research sites, we provide real-world experience, data and outcomes that lead to improved clinical utility of cancer therapies, improving the lives of cancer patients
Clinical Project Manager
We hire exceptional people. We want individuals who thrive on being challenged and are passionate about building a great company as well as growing with us. If you want your next step to be the right one and you’ve worked hard to get where you are today, then we have the perfect opportunity for you.
This position is responsible for ensuring project timelines and goals are met on time and within budget, while ensuring Good Clinical Practices (GCP), ICH, FDA, and best practices are followed. This includes utilizing expert working knowledge to anticipate project roadblocks and solve problems efficiently and effectively. As a Project Manager, you will be the primary liaison between Oncotherapeutics and its’ clients (Sponsors and Sites), ensuring questions are answered and issues resolved. You must clearly demonstrate the ability to manage multiple projects with different sponsors and timeline demands.
Your primary responsibilities as the Clinical Project Manager will include:
- Manage several multi-site clinical trials throughout the lifetime of the project. Lead study start up process, including but not limited to Trial Kick-off meeting, the set-up of the trial master file (TMF), the set-up of the electronic data capturing (EDC) system, site selection and the finalization of site Clinical Trial Agreements and budgets.
- Develop project plans such as data management plan (DMP), case report forms, data management plan, source document worksheets, central laboratory specifications, etc.
- Maintain the TMF up to date, set-up, and maintenance of the investigator site file (ISF) for all participating sites.
- Manage clinical research associates (CRA’s), review and approve site trip reports; Oversee tracking, follow up and resolution of site issues. Assist in source data verification (SDV) as needed.
- Conduct site initiating visits (SIV), provide guidance on protocol and proper collection of data.
- Organize and prioritize work according to study timelines and proactively address potential problems; Create tracking tools for weekly internal meetings and monthly reports to clients.
- Create effective and professional relationships with sites, vendors, and clients to ensure project goals are met. Act as liaison between Oncotherapeutics, sites and sponsors.
- Ensure adherence to GCP, ICH, and FDA regulations and guidelines and international regulations.
- Prepare study regulatory documents, FDA, and IRB submissions such as yearly reports/renewals, SAEs, etc.; Manage submissions and distribution of documents to sites of protocols amendments, informed consent forms, investigator documentation, safety reports and recruitment materials.
- Assist Medical Writer with creation of trial protocols, schedule of procedures, and informed consents, as needed.
- Provide efficient updates on the trial progress to Director of Clinical Operation and CEO. Ensure potential risks are escalated to the appropriate team.
You should have:
- Bachelor’s degree in a scientific discipline
- Minimum of two years’ experience in clinical trial project management
- Therapeutic experience in oncology, preferred.
- Must be able to work independently as well as establish and maintain effective working relationships with co-workers, supervisors, and other staff. Excellent interpersonal abilities required.
- Must have thorough knowledge of clinical research concepts, practices, and FDA regulations and ICF Guidelines regarding drug development phases, clinical research, and data management methods.
- Ability to solve problems. Must have effective time management and organizational skills.
- Read, write, and speak fluent English. Excellent verbal and written communication skills.
- Willing to wear many hats in a growing company.
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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