Description

Alcyone Therapeutics is a therapeutic technology company developing precision delivery platforms for the treatment of neurological and oncological disorders. Under the direction of the Senior Manager of Clinical Operations, the Clinical Project Manager will be responsible for the development and management of multiple aspects within clinical affairs operations. 

The Clinical Project Manager will lead the clinical programs for Alcyone’s sponsored and investigator-sponsored clinical trials and assist in pre-clinical development, clinical training, and both clinical trial or commercial case coverage as needed. This role will provide direction and support to ongoing projects, ensuring that best practices for project management are implemented.

The candidate will be expected to drive essential clinical study documents to completion, manage and oversee the successful execution of clinical studies, interact with Investigators, customers, Key Opinion Leaders, and other stakeholders to support strategic initiatives on behalf of the company.

Candidate will provide leadership, project management, and program oversight to plan and conduct one or more high quality clinical trials concurrently in accordance with regulations and support of regulatory authority submissions. The candidate will be expected to develop, implement, and amend high quality essential clinical trial documents (Protocol, Informed Consent, Case Report Forms, Investigators Brochures), training plans for internal personnel (field clinical engineers, clinical specialists, trial monitors) clinical research (site Investigators and research personnel) and commercial sites (Physicians and other Health Care Professionals). 

This position will be based at Alcyone Headquarters in Lowell MA and will be focused on developing and managing our own IDE Clinical Studies. This role will be responsible for setting up and supporting our collaboration partners’ IND studies. 

Requirements

The Clinical Project Manager will manage multiple operational aspects of assigned clinical and commercial development projects. Open effective, and proactive communication of the clinical development activities is critical for success in this role. Must have an excellent understanding of the drug/device development process in order to effectively manage internal and external cross-functional teams. Must have strong work ethics and be able to work independently and productively. Must be willing to travel up to 50% with little notice and adhere to site vendor credentialing requirements.

To perform this job successfully, an individual must be able to perform each essential function satisfactorily:

• Coordinating the flow of information between team members and functional management and will be experienced in exercising leadership to resolve multidisciplinary conflicts to ensure implementation of Alcyone’s program calendar.
• Assisting with leading & developing project management training & initiatives and building organizational skills across current platform programs to facilitate the creation of a self-sustaining culture of accountability.
• Supporting efficient day-to-day management of the trial(s) through recruitment, training, and supervision of clinical trial activities and resources. 
• Developing internal and external company wide training, implementation, and monitoring plans for clinical and commercial sites. 
• Contributing to product design development in human factors engineering. 
• Provide and support cross-coverage for clinical and commercially released products.
• Establishment of procedures to ensure adherence to trial protocols and administrative requirements. 
• Ensuring the timely recruitment of trial participants with secure randomization processes and subsequent efficient and effective data management. 
• Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems. 
• Acting as the point of contact for all external and internal agencies (Data Management Vendors, Contract Monitors, etc.). 
• Acting as the liaison, for clinical research and commercial sites. 
• Coordinating the preparation and publication of data, reports and information, ensuring that they meet legislative, contractual and ethical requirements. 
• Supporting clinical research focused company regulatory affairs efforts (submissions, amendments, etc.) as needed.
• Understanding the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements. 
• Acting as a liaison with the Trials Steering Committee and Data Monitoring and Ethics Committee with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements. 
• Working with investigators and Alcyone management to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time. 
• Planning and supporting the meetings and work of the various groups and bodies associated with the trial. 
• Participating in quality improvement efforts, including implementing corrective and preventative action plans within clinical sites. 

Education/Qualifications:

• University/college degree required, Masters Degree preferred in life sciences, nursing or related allied health profession.
• In lieu of this required educational background the following relevant work history may be considered: 

- Minimum of three (3) years supervisory experience in a health care or clinical research setting with ACRP/SOCRA Certification or willingness to acquire.

- Minimum of four (4) years relevant clinical research experience in a pharmaceutical or medical device company/CRO