Senior Clinical Project Manager
Company: Akebia Therapeutics, Inc.
Posted on: May 3, 2021
The Senior Clinical Project Manager (Sr. CPM) is responsible for
orchestrating clinical operational activities across one or more
compounds that are in development. The Sr. 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 Sr. CPM is responsible for the execution of one or more
trials, 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 Sr. CPM is
responsible for coordinating efforts for the management of assigned
studies both within the Company and through a variety of
This role may oversee one or more indications within a single
compound or multiple compounds and is differentiated in
responsibility by large, complex, global trials that require
specialized technical and clinical expertise. Each indication will
be developed in clinical studies performed on a global scale in
coordination with international Clinical Research Organizations.
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 Associate Director/Director of
Clinical Operations or above.
- 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 with minimal oversight - Protocols,
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
- Manage and lead cross functional study teams, including
- 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 ongoing studies.
- Proactively identify and resolve issues and manage escalation
- Utilize appropriate systems and standard processes to ensure
quality and consistency of operational activities across studies
- Plan and execute Investigator Meetings, Advisory Board Meetings
or other scientific meetings as required. Establish working
relationship with clinical and internal and external medical
experts to optimize and implement clinical studies.
- Drive process of CRO review, selection, and negotiation for
- Develops and maintains 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.
- Participate in process improvement and quality related
initiatives associated with study execution and deliverables.
Participate in establishment of best-in-class processes and
standards for study conduct.
- May serve as subject matter expert (SME) in one or more areas
such as systems, tools, best in class standards for operational
- BA/BS degree
- 5 years of experience in clinical research operations of which
3 years must be direct study management experience in the
- Global study experience.
- Must have multi-trial, Phase2/3, global experience.
- Experience in managing all stages of study conduct (start-up,
maintenance and completion).
- BA/BS degree in science or nursing
- Multiple therapeutic areas experience is desired.
- Experience Managing CRO's and multiple Vendors
- Demonstrated knowledge and experience in the global 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
- Must have strong knowledge of ICH/GCP guidelines and regulatory
- Experience in the following therapy areas is desirable: anemia,
chronic kidney disease, dialysis, and/or oncology.
- Experience responding to audits and inspections.
- Proven advanced project management expertise, including the
leadership and development of cross functional teams and study team
- Exceptional organization and attention to detail.
- Excellent interpersonal, oral and written communication and
presentation skills. Effectively present to leadership.
- Fluent in English (oral and written).
- Moderate travel (25%) may be required.
Keywords: Akebia Therapeutics, Inc., Cambridge , Senior Clinical Project Manager, Other , Cambridge, Massachusetts
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