Regional Clinical Lead - Europe

Location Philadelphia
Contact name: Christopher Blohm

Contact email:
Job ref: 831
Published: 15 days ago
Key Characteristics of the job (Objectives and Responsibilities)

The Regional Clinical Lead (RCL) will focus on oversight of rare disease studies at investigative sites, and ensure that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.  The RCL will be responsible for effective management of relationships and communication with CRAs, investigators, site staff, clinical study team, cross-functional team and other external partners. Responsibilities include, but are not limited to:
  • Engage study site personnel (i.e., Principal Investigator, Sub-Investigator(s), study coordinators, other HCPs, etc.) in discussions to:
    • maintain focus on overall study design, rationale, and eligibility criteria
    • identify operational hurdles/challenges and offer potential strategic solutions; apply mitigations broadly between sites and across studies
    • ensure quality execution of clinical studies
  • Study Start up: involved in feasibility, site selection, document development and review, as requested
  • Performs monitoring oversight of CRO CRAs including: qualifying site assessments, initiation, interim and closeout when necessary. May also visit investigator sites without CRO personnel
  • Builds partnership with CRO CRAs and performs oversight visits:
    • Review previous monitoring visit reports and follow-up letters, meet with CRAs prior to visit to discuss visit plan, observed CRA’s visit conduct, professionalism, comprehension of the study protocol(s), protocol-related procedures, and visit findings during conduct of monitoring visit.
    • Document any visit findings observed, review visit findings with the CRA, and observe CRA meeting with PI and site staff, providing assistance/feedback when necessary.
    • Following the completion of each accompanied visit, reviewed CRA draft visit reports and follow-up letters for completeness and accuracy, providing feedback/comments when necessary, and complete sponsor oversight accompanied visit report, and escalate any findings.
    • Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to study team
    • Maintain and update Monitoring Visit Oversight Trackers
  • Support patient recruitment and retention initiatives; ensure full leveraging of recruitment and retention tactics by CROs and clinical sites
  • Identify and proactively mitigate challenges related to protocol conduct at study sites; strategically reviews protocols to ensure operational clarity for investigator sites; collaborates with the Study Team to develop the baseline timelines and milestones
  • Help facilitate investigator meetings especially related to local considerations and relationship building with the site personnel and CRO
  • Participate in CRO meetings, as requested
  • Identify and develop needed internal procedures; delineate and communicate responsibility divisions across adjacent roles (i.e. CRO CRA, Sponsor study lead); identify key performance indicators applicable to this role
  • Identify, communicate and implement lessons learned across sites, regions and studies
  • Collaborate and align with study team, Medical Affairs, and Commercial on clinical investigator engagement and document site interactions to ensure cross-functional alignment
  • Support Medical Affairs team to establish a KOL network around the globe
  • Support Medical Affairs in the organisation and execution of local events (advisory board meetings, symposia, patient board meetings)

Job Holder Requirements/Key competencies:
  • BS/BA degree or equivalent (background in life sciences preferred)
  • 5+ years of field monitoring and management within the pharmaceutical industry performing pre-study visits, initiation, interim and close out visits
  • Monitoring Oversight experience
  • Site relations experience
  • Excellent verbal and written communication skills as well as interpersonal and organisational skills
  • Experience with EDC systems
  • Knowledge of current regulatory requirements and guidelines governing clinical research (e.g. ICH-GCP) and Understanding of compliance in interacting with the medical community
  • Proven ability to demonstrate strong decision making and problem solving skills
  • Attention to detail; ability to prioritise and handle multiple tasks effectively
  • Ability to work within established timelines, in a fast paced environment
  • Ability to work both independently as well as in a team environment
  • Experience/interest in medical affairs topics
  • Good negotiation skills
  • Ability to travel; 50% travel
  • Preferred:
    • Experience in Rare Diseases