- Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with agreed upon study plans through regular CRO and/or investigator site contact.
- Represents and leads the Study Team to design, develop and deliver the study to agreed upon timelines.
- Provides project coordination and communication in support of cross-functional experts (internally and externally).
- Facilitates decision-making, collaboration, and problem-solving with all levels of the organization to accomplish shared program goals.
- Provides oversight and management of CROs and vendors.
- Monitors progress of clinical activity and reports on progress of assigned clinical trials including budget and timelines.
- Anticipates bottlenecks, clears barriers to progress, conducts project level scenario planning & risk management.
- Coordinates and leads all aspects of internal project meetings, including agenda drafting and clear documentation of key discussion points, decisions, and action items.
- Communicates project information and develops project presentations for senior leadership, and other key stakeholders. Presents on-going study updates to Clinical Leadership.
- Champions best practices in Project Management, including use of agendas, minutes, maintaining document repository, establishing, and implementing templates, tools, and processes to drive efficiency, alignment, communication, and effective planning.
- As needed, supports oversight of contracts and outsourced activities with vendors and business partners.
- Monitors status of clinical data collection of assigned clinical trials.
- Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
- Develops study-related documents.
- Reviews and approves study-related plans generated by CROs/vendors. Ensures documentation is in accordance with GCP, regulatory requirements and consistent with the protocol.
- Assists study team with preparation for audits/inspections.
- Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, and CSRs.
- Prepares and delivers program/study updates.
- Manages escalation of study related issues and communicates as appropriate to management.
- Evaluates issues found in clinical studies. Communicates effectively and provides oversight of CROs/vendors. Suggests and implements solutions and mitigations as required.
- Anticipates bottlenecks, potential study issues and clears barriers to progress project level scenario planning and risk management.
- Contributes to development of RFPs and participates in selection of CROs/vendors.
- Provides oversight for setup, maintenance, and close out of the Trial Master File and ensures its completion and inspection readiness.
- Assures compliance with internal SOPs, FDA regulations and GCP.
- Provides input as the subject matter expert for assigned studies during regulatory inspections.
- May simultaneously lead/manage more than one clinical trial.
- Bachelor's degree in Life Sciences, Chemical Sciences, Physical Sciences or other relevant discipline or equivalent experience. Advanced degree welcome.
- Must be willing to work on site.
- Minimum 5-7 years of experience in biotech/pharmaceutical industry,
- Oncology drug development experience preferred.
- Managerial experience preferred.
- Proven expertise and experience with successfully resolving problems while also being thoughtful and proactive about risk mitigation.
- Excellent project management skills - drives execution while balancing speed, quality, and cost.
- Excellent interpersonal skills, including ability to successfully influence individuals in a matrix environment.
- Experience with commonly used project management tools including but not limited to Microsoft project.
- Understanding of Good Clinical Practice (GCP) guidelines and FDA regulations.
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Project Manager/Sr. Project Manager Clinical Trials - Shelton, United States - Intensity Therapeutics Inc
1 month ago
Description
This position reports directly to the VP, Clinical Operations. We are seeking a Project Manager, Sr. Project Manager, Clinical Trials with experience in the biotechnology/pharmaceutical industry.Selected candidate will be responsible for cross-functional planning and execution of Intensity's clinical trials including: managing cost, timelines, quality, risk assessment and mitigation.
Must have the ability to work in a fast paced environment with high attention to detail, along with a collaborative positive work style.
Position responsibilities include:
Qualifications and Education Requirements:
If you are passionate about clinical trial project management and have the skills necessary to excel in this role, we encourage you to apply and forward your resume in confidence.
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