Clinical Project Manager - Rare Disease

Harbor Clinical is seeking an experienced Clinical Project Manager to manage Clinical Trial Team activities across assigned project(s) within the Rare Disease therapeutic areas specifically von Willebrand or Bleeding Disorders. The CPM is accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.

Responsibilities

• Writes study protocols, study reports, and regulatory documents (e.g. IND, NDA, PRAC etc.) with little supervision
• Contributes to development of abstracts, presentations, and manuscripts
• Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
• Partners with cross functional teams to manage, adjust, and revise project timelines/budgets as necessary
• Communicates project status and issues and ensure project team goals are met
• Represents the department at cross-departmental events
• Developing RFPs and selection and management of CROs/vendors
• Contributes to SOP development, implementation and training
• Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals
• Resolves problems using national and international regulations, guidelines and investigator interaction
• Collaborates with local medical affairs colleagues on country specific studies and initiatives
• Provides knowledge and expertise on country specific regulations, site experience, and suitability for development studies

Qualifications/Requirements

• 6+ years of experience with a pharmaceutical company or contract research organization
• Excellent interpersonal skills and demonstrated ability to lead is required
• Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision
• Ability to examine functional issues from a broader organizational perspective
• Strong communication and influence skills and ability to create a clear sense of direction is necessary
• Thorough knowledge and understanding of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCPs governing the conduct of clinical trials and noninterventional studies
• Strong verbal and written communication skills with ability to communicate and work productively in a team environment
• Proficient computer skills i.e. Microsoft Project, Word, PowerPoint, and Excel
• Excellent organizational skills, ability to work independently and with moderate guidance