Site Relationship Manager

Job Title: Site Relationship Manager

Location: Cambridge,MA
Duration: 12+ months (possibility of extension)


JOB ROLE:

· The Site Relationship Manager (SRM) within Value Based Medicine (VBM) will be responsible for the overall US site management, training and quality oversight of assigned studies.

· These studies will explore new technologies to generate, collect and present patient data seamlessly within the clinical practice setting.

· The goal of the studies is to explore innovative ways to learn from clinical practice and generate insights that can be used to inform decision making at the point of care.

· The SRM will execute site management and provide oversight of site training and quality in accordance with Clients SOPs/processes.

· This position will also take on additional project management responsibilities as delegated by the Clinical Operations Lead.

· This position will report into the Project’s Director within VBM.

· It is strongly preferred that the SRM will be based within the Cambridge area to commute to the Clients Cambridge office on a regular basis.

· This role requires an individual with demonstrable clinical operations experience and proven expertise in customer service.

MAIN ACCOUNTABILITIES:

· Conducts Site Visits to orient and train site personnel regarding the protocol, study activities and applicable regulatory requirements.

· Assures ongoing site compliance with the protocols, informed consent process and documentation, as well as applicable FDA regulations and/or ICH GCP Guidelines and other local regulations critically reviews and analyses site activities and study conduct through on-site and remote assessments/contacts.

· Ensures timely submission of high quality of data from study sites and appropriate query resolution.

· Ensures safety and protection of study subjects according to the monitoring plan, and applicable Clients SOPs, and ICH GCP Guidelines and/or FDA/local regulations.

· Proactively works with sites to resolve issues, answer questions, and manage requests for study supplies.

· Interacts and builds professional and collaborative relationships with all study personnel and Clients personnel in order to facilitate meeting study objectives.

· Takes on aspects of the project management as delegated by the sponsor, including development of study reports and trackers, quality metrics and risks and mitigations.

· Responsible for development of study monitoring and management documentation and tools as delegated by the sponsor, including: Clinical Monitoring Plan, SIV slides, Regulatory Binder, Study Reference Guide, site tools, etc.

· Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.

· Proactively communicates and escalates with all internal and external stakeholders issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.

· Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.

· Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites including site specific ICFs and essential documents.

· Uses multiple technologies to foster, maintain, and enhance open communication.

· Train, mentor and maintain oversight responsibilities of additional Site Relationship Manager(s) assigned to the studies.

· Communicates and provides oversight of specified vendors for quality and compliance. Performs on-site visits with specified vendors as applicable.


QUALIFICATIONS:

· Minimum of 7+ years of clinical research experience with minimum of 5+ years of CRO/sponsor monitoring.

· Flexibility in travel to sites as needed.

· Expected to be on average 50% of time based on project needs.

· Strong customer service and relationship building skills with sites (on site and remote).

· Strong Site Management and Project Management skills including risk assessment and contingency planning.

· Demonstrate a high degree of learning agility.

· Possess a combination of critical thinking and operational know-how and efficiency.

· Demonstrated success in working independently.

· Strong communication and leadership skills

· Strong preference for candidate local to the Clients Cambridge office to work on campus routinely

· Strong preference for experience with late phase and observational clinical research
CNS and MS experience preferred

EDUCATION:

· Minimum of a Bachelor of Science degree in a health related field with clinical research experience