Posted in Other 13 days ago.
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
A Biotechnology Company is seeking a Clinical Project Manager-Rare Disease in Rockville, MD.
As Clinical Project Manager (CPM), you will be responsible for the planning and implementation of one or more clinical trials within a therapeutic area and manage the day to day execution of the trial and ensure the execution is meeting the operational plans and company goals. You will be responsible for the execution of the clinical trial end to end, including collaborating to develop and drive protocol completion, database and IVR build, safety operational plans to meet the overall development strategy and will ensure that clinical trials are conducted in a timely fashion and compliant.
• Develop and maintain the clinical trial deliverables including timelines, budgets, and resource requirements within a therapeutic area
• Attend and support the clinical sub team
• Provide matrix management of cross functional representatives to manage clinical execution deliverables
• Define and manage accountabilities for CTT team members and supports the CST as required
• Review and refine clinical operations plans for each study
• Develop and construct content for risk mitigation plans related to the study to ensure clinical trials are on time and within budget
• Implement clinical trial ensuring that clinical trials are conducted in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets
• Partner with clinical development and cross functions to draft the Clinical Protocols, Investigator's Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs), and manage timelines for completion of these documents.
• May lead selection process for outsourced activities,
• Lead the selection of specialty vendors (if needed) including development of scope of services agreements, budgets, and plans and timelines
• Manage CRO/vendor agreements, ensuring that change orders and budgets meet clinical operations specifications
• Review invoices for accuracy compared to operational plans, budgets, and work known to be performed by CRO/vendors
• Lead ongoing review of data to ensure quality and consistency through study execution
• Manage CRO/vendors to achieve goals and ensure that performance expectations are met
• Responsible for working with the CRO to plan everything from early engagement for protocol feedback to database lock.
• Participate in patient identification activities and the development of patient recruitment plans and back-up plans
Identify, recruit, and approve clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership
• Ensure that all supportive study-related documents are completed (e.g. Monitoring Plan, IXRS, Study Reference Manual, Laboratory Manual, Pharmacy Manual, CRF Completion Guideline, etc.)
• Ensure that all monitoring activities and processes are complete, including training of internal and external resources, and are compliant with SOPs and GCP/ICH/regulatory guidelines
• Ensure quality of data generated from clinical sites and assist in resolving patient eligibility and protocol deviation issues
• Manage internal supporting staff to ensure that all activities are moving according to trial timeline
• Recommend and implement innovative process ideas that impact clinical trials and/or clinical program management
• Participate in the development of clinical operations quality systems, including SOPs, document management, clinical operations personnel training, and quality control processes
• Contribute to wider organizational goals and/or activities as assigned
• Mentor and coach junior Clinical Operations team members on assigned studies
• Support the clinical operations lead and clinical trial team by performing other tasks as needed
• Travel up to 25% of the time is required
Skills & Requirements
• BS degree with minimum of 6 years relevant industry and 2 years project management experience
• MS degree with minimum of 5 years relevant industry experience and 2 years project management experience
• Ability to independently drive and execute all aspects of a trial
• Ability to prioritize project activities across multiple studies and set clear objectives to achieve study milestones
• Demonstrate leadership, interpersonal, and facilitation skills and the ability to delegate as appropriate
• Proactively identifies risks, provides possible mitigations, and participates in process improvement initiatives as necessary or required
• Ability to think independently and creatively to problem solve and find solutions to unique challenges and obstacles with appropriate escalation as needed
• Demonstrate understanding of change management of contracts, budgets, timelines, and metrics
• Contribute to implementation of clinical development plan
• Thoroughly understands the drug development process, including cross-functional links and dependencies
• Demonstrate strong communication, conflict management, and decision-making skills
• Ability to motivate and influence through effective and collaborative relationship building
• Ability to navigate in ambiguity
• Has in-depth knowledge of ICH-GCP and its application to clinical trials
You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
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Hays is an Equal Opportunity Employer.
Drug testing may be required; please contact a recruiter for more information.