Clinical Project Manager
To apply for this position, please apply directly on our website or follow this link to the Clinical Data Manager position.
The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being, and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally, and internationally.
Program Summary
Children’s Oncology Group (COG), a project of PHI, is a National Cancer Institute (NCI) supported clinical trials cooperative group, and the world’s largest organization devoted exclusively to childhood and adolescent cancer research. Clinical research is conducted at more than 200 member institutions, which are leading children’s hospitals, universities, and cancer centers throughout the United States, Canada, Europe, Australia, and New Zealand. COG’s over 9,000 multi-disciplinary cancer researchers, affiliated with the network of member institutions, provide access to state-of-the-art therapies and the collective expertise of world-renowned pediatric specialists to children with cancer, regardless of where they live. Today, more than 90% of 14,000 children and adolescents diagnosed with cancer each year in the US are cared for at Children’s Oncology Group member institutions.
Position Summary
The Clinical Project Manager will be responsible for managing COG projects that involve outside collaborators and the pharmaceutical industry. The Clinical Project Manager will ensure COG maintains its contractual commitments, act as liaison between COG and its outside collaborators and industry partners and assist with the financial management of industry trials.
Essential Duties & Responsibilities
- Manage active projects with outside collaborators and drug companies.
- Maintain tracking system for active agreements.
- Establish routine meetings with outside collaborators, industry contacts and/or study committee members over the lifetime of a study to foster open lines of communication and to provide a forum for discussing study specific issues. Address minutes/action items resulting from those calls.
- Communicate pertinent information on behalf of the outside collaborator, drug company and/or study committee to COG institutions, IST Director, and/or COG Leadership.
- Facilitate the review of protocols, informed consent documents (ICD), case report forms (CRFs) and remote data entry screens to ensure that all data collection requirements are met as specified in the signed agreement and before study and/or amendment activation.
- Provide logistical support for industry trials.
- Develop drug distribution procedures and establish study drug accountability procedures in collaboration with outside collaborators and/or industry contacts.
- Work in partnership with outside collaborators and/or industry contacts to monitor and direct study drug supply/re-supply shipments to institutional sites.
- Manage the distribution of pharmacy materials to COG institutions such as drug order forms, accountability logs, and expiration notices.
- Work in partnership with outside collaborators and/or industry contacts on COG feasibility assessments and site start-up, monitoring or other outside services for trials.
- Communicate with COG personnel and membership regarding all requirements for participation that are beyond that expected for COG studies of the same phase.
- Manage the contract review, budget and scope of work (SOC) development and negotiation process. Ensure COG supplies all deliverables at time points agreed upon in the contract and/or SOW.
- Monitor agreed upon project timelines.
- Obtain required deliverables from COG functional groups and forward to outside collaborators and/or drug companies in accordance with internal policies and procedures.
- Manage payment milestones, coordinate invoicing, and institutional pay-outs associated with industry trials.
- Track payment milestones and provide the necessary documentation to submit invoices to outside collaborators and/or drug companies.
- Produce study enrollment and activity reports and associated back-up to indicate individual institutional payments associated with industry trials.
- Provide support to IST Director and applicable personnel in maintaining COG’s compliance with regulatory responsibilities.
- Work with outside collaborators and/or drug companies to coordinate the collection, scanning, storage, retrieval and delivery of applicable regulatory documents (e.g., FDA 1572s), patient files and other non-computerized documents.
- Along with the IST Director, develop written SOPs and policies to standardize internal processes related to industry trials.
- Coordinate with Administrative Staff that support industry trials.
- As needed, assist with onsite visits/audits by outside collaborators, industry sponsors or regulatory agencies.
- Participate and present at trainings, sessions, etc. related to industry-sponsored trials at COG Group Meetings.
- At the discretion of the IST Director, assist in other day-to-day operational tasks related to industry-sponsored trials specifically with regard to trial coordination and management.
Minimum Qualifications
- Bachelor’s degree in science or related field or a combination of education and work experience
- Five years of clinical research experience
- Project management experience
- Able to work accurately, consistently and efficiently on assigned projects; superior prioritization skills
- Independent, self-directed professional
- Excellent oral and written communication skills
- Ability to adapt to direct and indirect reporting relationships
- Knowledge of Microsoft Office applications
- Ability to learn job responsibilities efficiently and quickly
- Familiarity with scientific terminology
Desired Qualifications
- Background in oncology
- Working knowledge of GCP and ICH Guidelines
- Experience managing filing and maintaining INDs
Important Information
- This is a full-time (40 hours per week) position
- This position is not typically eligible for telecommuting, however, during the COVID-19 shelter-in-place order an exception will be made
- To qualify for this position, applicants must be legally authorized to work in the United States
The Public Health Institute is committed to a policy that provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and to make all employment decisions so as to further this principle of equal employment opportunity. To this end, the PHI will not discriminate against any employee or applicant for employment because of race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and will take affirmative action to ensure that applicants are offered employment and employees are treated during employment without regard to these characteristics.
To apply for any position, you must create an account on the Public Health Institute’s job application site. After creating your account, you may search the open positions and apply for the specific position that interests you. Please note, mailed and emailed applications will not be accepted.
We’re so pleased the Public Health Institute is an organization you would like to work with. Do you have questions about this opportunity? If so, email our recruitment team at Recruitment@phi.org.