Manager, Clinical Operations

Summary

Supervise the site relationship managers who will be accountable for building and managing clinical site relationships (investigators, site staff, KOLs etc.) for local, regional and global programs across different Therapeutic Areas that have been outsourced to a CRO Partner.

The main responsibility of this position is to develop, manage and maintain BMS's interface and long-term relationships with clinical sites for several outsourced studies and ensure a harmonized approach to site management with studies run in-house. It includes building and enhancing the image and reputation of BMS with sites locally and providing an interface between the company, the investigator and Partner CROs to create an optimal environment for clinical trials, enabling timely and high quality output.

Key Responsibilities and Major Duties ofSite Relationship Manager

On-going site relationship management in local country to enhance the development & maintenance of long-term relationships with clinical investigators working on studies outsourced to a CRO Partner.

Act as liaison between BMS, CRO Partner and investigational sites building overall investigator and site staff awareness on BMS in order to develop the image and reputation of the company.

Develop local knowledge of site (and local SMO) capabilities and past performance, and ensure local site / SMO related information is current.

Coordinate regular communication with clinical sites to align interactions with investigators, KOLs, Partner CRO, SMOs and relevant internal stakeholders to assure a harmonized approach to site management across the entire Book of Work.

In close collaboration with Partner CRO and the support of internal stakeholders such as Vendor Operations Manager, Medical Affairs, RCC and local development leads (Japan/China only):

Proactively work with sites to resolve issues, answer questions, and manage requests.

Interact and build professional and collaborative relationships with all study personnel and personnel in order to facilitate meeting current and future clinical trial objectives.

Anticipate and proactively solve study site problems/issues as they occur. Initiate, recommend and communicate corrective actions as needed.

Proactively communicate and escalate issues identified at study sites and develop corresponding mitigation strategies and recommended approaches.

Build and manage site relationships; channel information on trials for respective programs.

Use multiple technologies to foster, maintain, and enhance open communication.

Keep internal interested stakeholders appraised of identified issues, resolution strategy and outcome as well as insights gained from collaborating with the sites.

Oversee site-level activities of Partner CRO and provide technical advice where necessary (particular focus on study start-up and closeout activities)

Support activities associated with the evaluation and selection of investigational sites, investigators and SMOs in order to develop and build-up company network in a coordinated manner.

Provide input in to site-level recruitment forecasts, recruitment methodologies, monitor performance and take appropriate action to maintain timelines.

Assure that timely communication / correspondence with sites and quality standards are maintained by the Partner CRO.

Manager will be responsible for delivering on company objectives.

Degree/Certification/Licensure

Bachelors or Masters Degree within life sciences or equivalent

Experience

At least 4 years' experience in clinical research in Pharma, Biotech or CRO

Demonstrated experience of working directly with clinical sites and investigators.

Demonstrated customer service and relationship building skills with clinical sites (on site and remote).

Clinical site management experience, with a strong background in operational aspects of clinical research and clinical development outsourcing.

Competencies - knowledge, skills, abilities

Knowledge of ICH GCP and applicable local regulations governing clinical research along with basic medical and research knowledge.

Excellent networking skills to represent BMS with key local stakeholders.

Excellent written and verbal communication skills - able to interact with all levels of internal and external management.

Excellent negotiation, influencing and problem solving skills.

Self-motivated with proactive issue monitoring and management including risk assessment and contingency planning.

Possess a combination of critical thinking and operational expertise and efficiency.

Good verbal and written communication skills (both in English and local language).