SENIOR PROJECT MANAGER

Position Summary:

The Sr. Project Manager is the primary point of contact for the client and is responsible for facilitating integrated project delivery, oversight, and project management of all phases of project life cycle. The Sr. Project Manager’s goal is to ensure optimal project performance including overseeing project scope, managing resource utilization, meeting key timelines and milestones, complying with quality and compliance standards, and achieving high level of client satisfaction.

Responsibilities:

· Overall project management from project kick-off through Clinical Study Report (CSR) completion and FDA/other regulatory submission, ensuring that the project objectives have been met

· Direct the conduct of assigned projects and activities associated with the project

· Ensure compliance with FDA regulations, International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP), and Standard Operating Procedures (SOPs) for projects filed under a U.S. Investigational New Drug (IND), Investigational Device Exemption (IDE) or other FDA requirements

· Communicate effectively with internal and external members of senior management, the project team, investigators and site personnel, and expert physicians

· Lead the development, implementation and review of the Project-Specific Plans

· Manage resource and financial aspects of the clinical study

· Manage problem identification and resolution in order to adhere to the project timelines and budget

· Recommend outsourcing when appropriate and interact with appropriate project team members to ensure that outsourcing to Contract Research Organizations (CROs)/vendors will meet expected performance standards for quality, timeliness and budget

· Supervise the planning and facilitation of investigator meetings

· Review recruitment strategy for meeting target enrollment of clinical protocols against target project goals

· Develop a working knowledge of assigned protocols

· Design, write, and review draft protocols, draft Case Report Forms (CRFs), Informed Consent Forms (ICFs), operations manuals and other documentation required for conduct of a project

· Resolve issues regarding grant negotiations, budgets and contracts with investigational sites

· Oversee the review of Clinical Research Associate (CRA) visit reports to assure report adequacy and adherence to project-specific monitoring plans, applicable SOPs and FDA regulations and guidelines

· Review and approve expense reports for CRA visits

· Review and comment on draft analysis outputs (tables, listings, and graphs) to be incorporated into CSRs, integrated summaries and New Drug Applications (NDAs)

· Write drafts and/or review appropriate sections of the CSR

· Work with Data Management staff to review CRF data, and interface with study personnel to resolve data queries

· Conduct site visits for co-monitoring and auditing, as needed

· Assume certain duties of other team members in order to meet project goals

· Participate in interactions/meetings with regulatory authorities, as needed

· Assist with IND and NDA coordination and preparation

· Participate in bid defense presentations and meetings

· Collaborate interdepartmentally on the proposal development process

· Participate in the periodic review and revision of departmental policies and SOPs

· Other duties as assigned

Required Education and Experience:

· Bachelor’s degree (or equivalent) in life science, biological science, clinical research or any other healthcare field and 5 years experience as a clinical research professional with a CRO, pharmaceutical or biotechnology firm;
OR
Master’s degree (or other advanced degrees, e.g. MD, PharmD, PhD, etc.) in life science, biological science, clinical research or any other healthcare field and 3 years of experience as a clinical research professional with a CRO, pharmaceutical or biotechnology firm

· Certification as clinical research professional (ACRP or SOCRA) is preferred.

· Working knowledge of ICH-GCP guidelines and FDA regulations

· Extensive understanding of clinical research principles and processes

· Ability to apply working knowledge of clinical trial operations to manage overall project scope, budget and timelines

· Ability to drive projects to completion by proactively coordinating the efforts of external and internal partners

· Dynamic individual with ability to lead and motivate team members

· Strong verbal and written communication skills

· Ability to work effectively both independently and in a team environment

· Strong organizational and planning skills

· Excellent interpersonal and professional skills

· Excellent time management skills with the ability to prioritize responsibilities and multitask

· Self-motivated and detail oriented

· Ability and willingness to travel for work purposes (domestic and international)

· Proficient in Microsoft Office and able to learn appropriate software

* Contact Kelliann Quinn kelliannq@amarexcro.com