(Senior) Clinical Project Manager - Oncology (REMOTE)
The (Senior) Clinical Project Manager - Oncology manages and coordinates clinical project services for sponsors to assure project/program milestones are met according to contract and applicable regulations are followed.
Essential Job Functions:
- Performs project oversight in compliance with applicable client policies, regulations, international standards, and SOPs.
- Applies thorough understanding of FDA Guidelines, ICH, GCP, and other applicable regulations overseeing all aspects of clinical research projects (primarily inclusive of complex, full-service and/or global trials) to ensure sponsor requirements are met.
- Perform contract and financial management activities for assigned trials and serve as central point of contact with sponsor for project updates.
- Meet with resourcing lead and supervisor to assure project needs are adequately met for all assigned projects.
- Participate in business development activities, including proposal development and pricing and bid defense meetings, as required.
- Responsible for the management of US and Global projects and displays very strong customer relations skills.
- Responsible to organize Kick Off Meeting, internal and sponsor teleconferences, draft internal and sponsor team meeting agendas, host meetings and review/approve meeting minutes.
- Position requires careful management of budgets to maximize project profitability.
- Provides operational support for Clinical Operations.
- Provides leadership, training and coordination to matrix project team members that may include Clinical Research Associates, Clinical Project Associates/Specialists, Associate Project Managers, vendors, contractors, and consultants as required by the project.
- Demonstrates problem solving ability, taking into consideration sponsor deadlines as well as financial, quality, and other important project aspects.
- Ability to work with minimal supervision; able to confidently make project decisions that could have substantial impact on clinical, data quality, or regulatory issues.
- Contributes to the overall operations and to the achievement of departmental goals.
- Other duties as assigned.
- Bachelor’s degree in a life sciences discipline desired or equivalent training and experience.
- Strong Oncology experience required, must be recent experience within past 5 years.
- Must have a variety of oncology indications experience across Immuno-Oncology, solid and blood tumors.
- Must have a minimum 3 years of clinical project management experience in the CRO or pharma industry.
- Minimum of 5-7 years’ overall of clinical research experience; experience can be a combination of CRO/Pharma industry and Academia/Research institutes, with a stronger emphasis on the CRO/Pharma industry.
- Experience in leading multi-service project teams through a complete clinical trial or multiple trials at various stages is required.
- Good knowledge of clinical, regulatory, and data aspects of trials including, but not limited to field monitoring, data management, biostatistics, and medical writing.
- Advanced knowledge of FDA guidelines and review processes, ICH/GCP compliance and regulations. Knowledge of IND and NDA process preferred.
- Project management skills including client management, fiscal/contract management, cohort and vendor management, quality management is required; as well as strong time management skills and the ability to thrive in a fast-paced environment with multiple priorities.
- Solid Microsoft Office Suite (Word, Excel, Powerpoint) as well as experience with tools specific to clinical trial management (e.g. CTMS, EDC, IVRS, eTMF, etc.).
Knowledge / Skills / Abilities:
- Effectively communicates in clear, concise, professional manner with employees and senior management within company and with peer and senior level customer contacts.
- Strong fluency in English both verbally and in writing and effectively conveys issues and potential resolutions to team members and supervisors.
- Demonstrates active listening and excellent interpersonal skills and exhibits the ability to lead team using appropriate motivational techniques and conflict management approaches with integrity.
- Skilled at presenting topics to groups for the purpose of training, bid defense meetings or other public speaking opportunities.
- Demonstrates a high level of attention to detail and the ability to interact professionally with clients, team members, and investigational sites.
- Travel is required 10%, Domestic/International, Daily / Overnight.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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