Job Information
Beacon Hill Staffing Group Clinical Project Manager in Helena, Montana
Beacon Hill Life Sciences is actively recruiting for a Clinical Project Manager to work a contract assignment, fully remote. * Duration of assignment is at least 7 months, with possibility of extension. * Pay Rate is based on experience with range of $90 - $100/hour. * Assignment is fully remote, however must work east coast hours. * Work Schedule: Full-time, east coast time. * Travel may be required (10-20% of the time).The ideal candidate should have the following experience: * Must have several years of Clinical Project Management experience and being held accountable for the health of the studies. * Must have managed at least 1-2 studies, likely either in maintenance or close-out. * Must be able to work independently, however must have a good understanding of when to escalate issues and when to ask questions if unsure of something.SUMMARY:The Clinical Project Manager will be responsible for operational aspects of planning, implementation, execution, and management of one or more clinical research studies. ensuring clinical trial is completed within established timelines and of the highest quality.Oversee management of CROs, and third-party vendors to ensure work performed is in accordance to the Statement of Work and within the approved budget. Authors, reviews, and approves various study related documents and plans. Proactively evaluates study risks and works cross functionally to implement solutions and mitigations as required. Responsible for the financial management of assigned studies and develops and oversees study timelines in coordination with cross-functional team, COL, and Program team. Ensure inspection readiness from a global level by engaging trial team(s) and other stakeholders, with a focus on the Trial Master File (TMF) and general clinical preparedness. Responsible for ensuring that inspection lessons learned are captured and shared. Ability to appropriately escalate issues that are unresolvable at a study team level to the COL and other leadership as applicable.QUALIFICATIONS: * Bachelor's degree or nursing qualification is required. Scientific/health care field preferred. Exceptions can be made for individuals with multiple years of experience in Clinical Operations. * Experience (6+ years) working in relevant clinical research, preferably in clinical operations within a pharmaceutical company or CRO or similar organization. * Strong knowledge of clinical research processes and clinical research terminology. * In-depth knowledge of ICH-GCP guidelines and local regulations. * Knowledge of regulatory requirements and guidelines governing clinical research. * Superior organization skills. * Strong attention to details in composing and reviewing/editing materials. * Excellent analytical and problem-solving skills. * Ability to establish priorities, scheduling, and meeting deadlines. * Strong written, oral communication and presentation skills and ability to present at Team meetings. * Ability to reason independently and recommend specific solutions in clinical settings. * Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands under tight timelines. * Demonstrated leadership skills. * Ability to work successfully within a cross-functional team. * Ability to effectively interact with investigators, vendors, peers, and leadership. * Strong aptitude with relevant technology platforms (e.g., eTMF, EDC, CTMS, IRT/IVRS) and project management software programs.Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. Company Profile:Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.Learn more about Beacon HiTo view the full job description, click here