Note: The job is a remote job and is open to candidates in USA. Prevail InfoWorks provides eClinical technology products and related clinical operations services through a SaaS model for biotech, biopharma, device, and diagnostics customers. The Clinical Project Manager independently manages multiple clinical trials, oversees cross-functional project teams and vendors, serves as the primary sponsor liaison, and manages projects from study start-up through close-out while ensuring milestone delivery and regulatory compliance.
Responsibilities
- Manages the scope of work, objectives, timelines, quality of deliverables, and all other project management activities for assigned project(s).Accountable for coordinating deliverables across all functional areas to drive overall study timeline
- Develops and maintains comprehensive project plans covering all phases of the project and associated deliverables
- Manages third-party vendors such as partner CROs, diagnostic labs, SME consultants,, meeting planners, drug depots, etc
- Contributes to the development and management of budgets/scope of work, timelines and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks
- Oversees the maintenance of project management information and internal data tracking systems
- Identifies, evaluates, and manages project risks; develops and implements quality and risk management plans to minimize impact on project objectives
- Continually assesses resource capacity and ensures adequate internal resources are available to meet project deliverables and milestones
- Develops and implements continuous improvement initiatives for assigned projects to enhance the efficiency and quality of work
- Contributes to internal planning activities, including providing input on scope, timelines, and budget assumptions for initiatives and proposals
- Executes proactive trial management to identify challenges, develops effective mitigation plans and appropriately escalates to and informs all relevant parties
- Ensures management of trials are completed in compliance with ICH, GCP, global standards, local laws and regulations
- Supports client communications with status reporting, agenda, minutes and changes orders
- Maintains professionalism with external and internal stakeholders at all times, setting an example of leadership for project team members
- Direct supervision of all support staff assigned on a project basis. This includes cross-functional services such as supplies and logistics, data management, Pharmacovigilance, TMF managers, and software engineers and designers
Skills
- Minimum of a bachelor's degree with a major in science, nursing, or other health related field is required
- Minimum of 3 years progressive clinical project management experience is required
- Must have customer service orientation and be a proactive and effective communicator
- Excellent interpersonal and teamwork skills are imperative
- General knowledge of all applicable regulations (GCP, FDA, OHRP, HIPAA)
- Demonstrated proficiency with all Microsoft Office Tools
- Possess the ability to communicate and comprehend written and oral instructions
- Able to effectively present information and respond to questions from colleagues and customers
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Able to apply common sense solutions towards the execution of responsibilities
- The incumbent must occasionally lift and/or move up to 50 pounds
- Incumbent must have the ability to spend extended periods of time sitting and traveling via car, plane and/or train
- This job is performed in an office setting or remotely
- Experience serving as a site study coordinator, or within a clinical operations role at a CRO or sponsor company is desired
Benefits
- This job is performed in an office setting or remotely.
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