Clinical Operations Manager, Boston

Summary:

We are looking for a Clinical Operations Manager based in the Boston, MA area. The Clinical Operations Manager (COM) will be responsible for overseeing and managing US operational/clinical activities including clinical site engagement, CRO oversight and “on site supervision” to ensure ICG, GCP and protocol compliance. In addition, the COM will contribute to other clinical development activities as required.

The ideal candidate is an experienced clinical operations professional (e.g. CRA, CRM, clinical project manager) who is versatile, energetic and collaborative person with outstanding operational and communication skills and demonstrated ability to manage multiple parallel activities.

The position is full time in the Boston, MA area with ~50% travel (domestic) and frequent calls to Israel.

Role and responsibilities:

• Oversight and management of clinical operational activities in the US, including but not limited to: multi studies US supervision from Phase I-III, multi centers visits and any other required operational activity

• Establish and monitor programs/protocols/procedures, including but not limited to support protocol development, oversee the CRO, supervision of full protocol procedures on site, joining trainings and site visits on a routine base

• Support the evaluation of suitability of site personnel and facility for initial and ongoing conduct of clinical trial

• Engage the clinical site teams and maintain appropriate and effective communication with the sites and various partners and vendors

• Assist with maintaining study timelines including identifying and communicating trial issues that will impact budget, resources and/or timelines

• Support various clinical operations activities including the oversight and monitoring of CROs and other vendors, assisting with vendor evaluation during RFP, etc.

• Manage other clinical development and clinical operations activities and projects as required

​

Time commitment:

Full time position.

Location:

The position is based in the Boston, MA area. This position will report to a Head of Clinical Operations based in Israel.

Travel expectation:

Requires frequent (~50%) domestic travel (mostly to clinical sites).

​

Qualifications:

Education and experience:

• Bachelor's degree required, preferably in science, nursing, other biomedical discipline, or equivalent

• Minimum 5 years clinical operations experience as a CRA, CRM, CTM or equivalent – MUST; experience in a start-up company – preferred.

• Demonstrated clinical monitoring experience – MUST

• Experience in building relationships with medical personnel at clinical site(s) to achieve enrollment and other trial goals

• Experience in CNS and specifically movement disorders and neurodegenerative diseases – preferred

• Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials

• History of success in managing vendors

• Previous independent on-site monitoring experience preferred

​

Skills and abilities:

• Versatile and energetic with demonstrated ability to manage multiple parallel projects and assignments effectively

• Demonstrated problem solving abilities, strong decision making and organizational skills

• Strong interpersonal skills with reputation for collaboration with colleagues influencing up, down and across the organization

• Demonstrated ability to collaborate in a dynamic, unstructured and fast paced environment

• Outstanding verbal and written communication skills (including technical trial related documents writing/reviewing)

• Excellent presentation and training skills

• Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail           

• Flexible and willing to travel (domestically) up to 50% of the time; work across multiple time zones

• Excellent technical skills – Microsoft office – MUST; MS Project and CRM - preferred

​

​

If you wish to apply for this position, please email your CV to careers@prilenia.com