Clinical Trial Liaison Medical Affairs

Amplity has an exciting opportunity with one of our leading global pharmaceutical clients. The Immunology Site Leader (ISRL) will support enrollment of patients into clinical trials, acting as a liaison between sponsor and study sites. As an Amplity employee you will enjoy a competitive base salary, additional bonus potential, auto allowance, full benefit package including 401K, generous PTO, medical, dental, vision, paid holidays and more. We are looking for a LOCATIONS ISRL Residence near a major airport desired.

ISRL will be responsible for executing site engagement strategies to enhance patient identification, screening, and enrollment activities.  The ISRL shall endeavor to achieve these objectives by fostering PI and study site ongoing awareness of the clinical trials via in-depth clinical, scientific, and educational discussions as it relates to the applicable clinical trial protocol, including discussion of the inclusion and exclusion criteria and correct clinical study patient profile. Collaborating with Site Start Up/Site Activation/Clinical Leadership teams to support “Ready to enroll” status of site is expedited in line with program expectations.

While engaging with clinical site staff, the ISRL will use only materials and education provided by Company.  The ISRL does not engage with patients, nor does the ISRL perform a regulated function. The ISRL will engage with an estimated 15 study sites, or several study sites as mutually agreed upon by the parties, throughout the duration of the study.

Key Accountabilities

Day to day activities and responsibilities

• Attend a site qualification visit and/or site initiation to support site training and establish a relationship with the site (where applicable).
• Assist site in completion of feasibility requirements including site investigator profile questionnaire (where applicable).
• Develop site engagement plans and modify as needed throughout the trial by establishing regular check-in connection with each assigned site based on need (minimally 1 teleconference/visit/email every 3-4 weeks based on site responsiveness) in collaboration with the study Clinical Research Associate (“CRA”).
• Adapt study engagement strategy to country level action plan including portfolio/study messaging for enrollment after consultation and approval with Sponsor.
• Be a member of country site engagement team to create country specific action plans and solutions supporting the immunology-rare disease portfolio.
• Provide alignment and coordination while partnering with all study team stakeholders (Medical Science Liaison (“MSL”), Therapeutic Area (“TA”), Clinical Research Organization (“CRO”) counterparts, Clinical Trial Managers (“CTMs”), and local teams to create a strategic relationship with the site.  Ensure requests received from Principal Investigators (“PIs”) and/or site study staff are managed efficiently and effectively according to established processes.
• Gather insights on site progress as documented by the protocol for patient finding and identification and develop relationships to enhance.
• Support sites in development of referral networks.  Encourage site to enhance referral network by building relationships with healthcare providers (“HCPs”) who have the potential to refer to the study site by providing approved materials to arm the site to support referral network.
• Ensure all site engagement discussions are tracked in designated Sponsor system. Review feedback from all contacts to identify country and site level trends or opportunities noted immediately prior to and within 48 hours of each engagement.
• Follow up within urgent requests within 24-48 hours, less urgent inquiries within 1 week.
• Liaise closely with the relevant site study team members to gather insights into key performance indicators (“KPIs”) and site performance.
• Attend bi-weekly meetings with Company and CRO to discuss trial progress and deliver insights on site status.
• Attend investigator meetings to support sites.
• Identify and attend industry meetings with Company approval for the purpose of enhancing investigator engagement.
• As part of self-development, you are expected to keep up to date with clinical knowledge, published data and competitive product studies.
• Complete mandatory training (both study specific & company specific) in assigned timelines upon hire.
• Coordinate best practice and key learnings across sites.

Cross Functional Collaboration

• Carefully gather insights and information from PIs and report back to company to help develop clinical strategy via CRM tool.
• Work closely with . Clinical, CRO, Medical Affairs and other internal groups to communicate the output of the teams’ activities and sharing of information.
• Review CRO information on site status and site requests.

Compliance

• Operate in a highly ethical manner and comply with all laws, regulations, and policies.
• Complete mandatory training and refreshers in assigned timelines upon hire, as well as, when new policies, SOP’s, guidance are issued.
• Raises questions to management and compliance around any areas of uncertainty.

Essential Knowledge and Experience

• Bachelor's degree from an accredited university required. Terminal degree a plus.
• 4+ years with relevant experience in pharmaceutical, clinical, or medical industry.
• Immunology or Rare Disease experience a plus.
• MSL (Medical Science Liaison) or equivalent medical affairs/clinical operations experience e.g., CRA (Clinical Research Associate) preferred, with clinical trial background a plus.
• Patient enrollment experience advantageous.
• Knowledge of and relationships with strategic site/networks is preferred.
• Experience with clinical trial design, conduct and evaluation. Clinical trials experience and understanding of clinical trial methodology and management.
• Experienced with Microsoft Word, Excel, and PowerPoint.
• Excellent technical skills with meeting platforms including Zoom, Teams, and other software packages.
• Ability to work within the relevant National Pharmaceutical Codes of practice.
• Other duties and responsibilities as needed.
• Travel weekly as needed.
• Valid driver’s license and safe driving required.

Essential Skills

• Strong written and verbal communication skills, ability to present medical/scientific information in a clear and concise manner.
• Networking skills and confidence to interact with senior experts on a peer-to-peer level.
• Skills to identify, develop, maintain, and build advocacy with strategic sites/Networks
• Demonstrable thirst for knowledge (technical, clinical, medical, scientific) with an ability to assimilate information quickly, present clinical data clearly and concisely and discuss the statistical and clinical relevance in line with clinical development strategy.
• Self-directed; able to work with limited supervision, and contribute to team objectives.
• Develops reports and analyses setting forth progress, roadblocks, and appropriate recommendations for project success/conclusions.
• Ability to function well, both independently and within a team setting, in a dynamic, fast-paced environment.
• Project management skills – to deliver on complex tasks within timeframe and manage milestones.
• Experience of working in a matrix management environment, able to prioritize and orchestrate matrixed teams to drive approaches to success.
• Ability to drive innovation and solve problems in an ambiguous environment.
• Highest ethical standards.