Senior Manager, Clinical Project Manager

Akebia Therapeutics•Cambridge, MA

6d•Hybrid

About The Position

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary The (Senior) Clinical Project Manager (CPM) is responsible for orchestrating clinical operational activities across one or more compounds that are in development. The CPM executes high quality, integrated cross-functional plans for the project while adhering to appropriate standards and processes to ensure completion of project team goals in compliance with applicable GCP/ICH guidelines and other regulatory requirements. The (Senior) Clinical Project Manager is responsible for the execution of a clinical trial or suite of clinical trials from protocol design to the final clinical study report and applies best practices in the development, initiation, planning, execution, control and completion of studies. This position coordinates the activities of functional groups that comprise the project team, in a matrix management structure, to ensure proper conduct and timely completion of all projects. Additionally, the (Senior) CPM is responsible for coordinating efforts for the management of assigned studies both within the Company and through a variety of vendors. This role may also be responsible for supporting and bringing many activities in-house without the use of a Contract Research Organization. These studies will be submitted to health care regulatory authorities around the world such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This position will report to the Senior Director of Clinical Operations or above.

Requirements

BA/BS degree in science, nursing or related areas
5+ years of experience in clinical research operations of which 3 years direct experience in study management in the pharmaceutical industry managing Phase 1-4 clinical studies
Experience managing in-house trials with limited vendor support (i.e. writing clinical documents/ plans, managing the day-to-day operations of the trial without a CRO, building trackers, systems and tools, directly managing CRAs and selecting and directly managing vendors like Central Labs, SMOs, etc.)

Nice To Haves

Global study experience
Experience in managing all stages of study conduct (start-up, maintenance and completion).
Experience in the following therapy areas is desirable: anemia, chronic kidney disease, dialysis, and/or oncology.
Strong knowledge of ICH/GCP guidelines and regulatory requirements.
Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA.
Proven project management expertise, including the leadership and development of cross functional teams and study team leadership.
Exceptional organization and attention to detail.
Excellent interpersonal, oral and written communication and presentation skills.
Fluent in English (oral and written).
Moderate travel (25%) may be required including travel to the office

Responsibilities

Plan, initiate and execute clinical studies while adhering to budget, scope and schedule requirements
Participate in creation and/or review of all supporting documents for a clinical study – Protocols, ICFs, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc.to ensure seamless integration between clinical objectives and study performance
Develop and effectively manage budgets, timelines, and resources for assigned clinical studies and escalate variances within the established processes
Develop study plans and lead system set-up
Adheres to standards and processes in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Manage and lead cross functional study teams and establish/ maintain key internal and external stakeholder relationships to ensure deliverables/ study milestones are met, including vendors
Ensure training of internal and external team members on appropriate SOPs and processes and effective training of study team, study sites and vendors of assigned clinical studies
Responsible for up-to-date study and/or program information within relevant tracking systems and provide management with routine updates regarding the status of assigned studies
Proactively identify and resolve issues and manage escalation as appropriate
Utilize appropriate systems and standard processes to ensure quality and consistency of operational activities across studies and indications
Plan and execute Investigator Meetings, Advisory Board Meetings or other scientific meetings as required. Establish working relationships with clinical and internal and external medical experts to optimize and implement clinical studies
Participate in vendor review, selection, and negotiation for each study
Develop and maintain relationships with external vendors and/or consultants and contractors
Participate in the development and implementation of clinical operations standard operating procedures and common work practices within the team