Clinical Project Manager:     

Frederick, Maryland

·         Manages assigned clinical research projects on time, within budget, and in compliance with FDA and other applicable regulations, ICH GCP guidelines, and SOPs. Manages CROs and other vendors to ensure quality service and clinical study conduct.

·         Evaluates and participates in selection of consultants, CROs and other vendors, and study sites to perform clinical research activities.

·         Ensures that the clinical study sites, CROs, and other vendors are in compliance with GCPs and relevant SOPs.

·         Oversees activities associated with clinical projects. Prepares necessary clinical documents, such as protocols, guideline informed consent forms, investigator brochures, transfer of regulatory obligations (TORO) forms, and study operations manuals.

·         Prepares and reviews Statements of Work (SOWs) and Requests for

·         Proposals (RFPs). Oversees team(s) collecting essential regulatory and other study-specific documentation related to assigned projects.

·         Has primary project management responsibility for one or more moderately to highly complex clinical research projects. Develops clinical development plans and timelines for clinical research projects.

·         Develops and updates SOPs and study-specific procedures pertaining to management of clinical studies and Clinical Research Dept activities according to GCP.

·         Reviews, revises and updates clinical documents such as Investigator Brochures, study reports, safety reports, and clinical sections of Annual Reports, INDs, marketing applications (BLAs/NDAs), and briefing documents; work with internal staff, consultants and medical writers.

·         Mentors clinical project manager(s).

·         Creates and implements complex project definitions, schedules, budgets, and objectives for a large sized or multiple projects of high complexity.

·         Determines need for and impact of changes in scope of project and makes and implements recommendations based on determinations.

·         Gains concurrence, approval, and consensus from stakeholders regarding the various project aspects, adjusts accordingly.

·         Identifies appropriate resources and staffs projects.

·         Organizes project team(s) members to ensure communication and understanding of deadlines, assignments and objectives. Acts as the point of contact to client's project management.

·         Manages costs, schedules and quality by overseeing project deliverables. Ensures schedule and budget are met. Identifies need for change, determines course of action and revises as appropriate.

·         May act outside of established policies as necessary.

·         Oversees the ongoing review of project(s) status; identifies risks.

·         Develops, recommends and implements risk mitigation solutions and implements as appropriate.

·         Works in conjunctions with team members and stakeholders to anticipate and manage changes to projects, such as but not limited to, technical requirements, business requirements and schedule.

·         Determines when additional resources are needed and implements same.

·         Identifies or gathers information regarding possible solutions that may create additional, different or unique project objectives or results.

·         Manages client project management, company management and project team expectations for agreed upon project performance by obtaining and providing project metrics.

·         Develops and makes presentations that could lead to expanded business opportunities.

·         Participates in proposal efforts and sales calls to enhance opportunities for future business deals with client.

·         Manages client expectations and balances the needs of company and client to ensure satisfaction for relevant parties.

·         Selects and hires employees. Trains and evaluates employees to enhance their performance, development, and work product. Addresses performance issues and makes recommendations for personnel actions.

·         Motivates and rewards employees including providing salary increases, bonuses and promotions within allocated budgets and company guidelines.

·         Prepares and recommends operating and personnel budgets for approval.

·         Monitors spending for adherence to budget, recommends variances as necessary.

Requirements:

·         Bachelor's Degree in a scientific discipline or equivalent; advanced degree preferred.

·         Minimum of 7 or more years clinical research experience in pharmaceutical/biotech industry or equivalent area with at least 5 years in clinical research project management.

·         Must have thorough understanding of FDA regulations, GCP/ICH guidelines and clinical development process.

·         Demonstrated experience in management, supervisory, mentoring, and leadership roles and experience with study implementation, CRO and vendor management, and clinical project management.

·         Proficient computer skills to facilitate communications, track and management projects, and preparation of effective presentations to management and customers (proficiency in MS Word, Excel, PowerPoint, MS Project).

·         Excellent oral and written communication skills.

·         Experience related to clinical operations, e.g. development of SOPs, staff development and training, resourcing/staffing, and budget planning and execution. Preferred experience includes experience managing all aspects of clinical trial from protocol writing through final report; experience in phase 1 through 3; and experience working with pharmaceuticals as well as biologics, especially vaccines.

·         Flexible work hours to meet department deadlines.

·         Full-time position. Travel required <10%

Other Qualifications:

·         Strong leadership and organizational skills

·         Strong analytical and problem solving skills

·         Strong interpersonal and presentation skills for interacting with

·         team members and clients

·         Strong communication skills

·         Good personal computer and business solutions software skills

·         Good human relations skills to select, develop, mentor, discipline

·         and reward employees

·         Good leadership and negotiation skills to manage project and develop

·         new business

·         Ability to work in a team environment

·         Ability to manage large or multiple projects with changing priorities

·         Ability to deal with ambiguity and change

·         Willingness to travel