Job Description: Clinical Engagement Lead
The site Engagement Leader builds partnerships and commitment by active elicitation of information on site specific processes and feedback on trial design. During the trial, sustained engagement encourages bidirectional communication and facilitates learning networks for enhanced site performance. Moreover, site and community partnerships are leveraged to create locally designed dissemination plans for broader scientific reach and impact.
Responsibilities:
To ensure study remains on each site top priority list using an innovative site centered approach, establishing preferred connections with sites. Works very closely with the Medical team, to review steering committee charter, publication rules (favorizing sites competitions) always in the context in strengthening site engagement to the study.
- Organizes regular Regional Group calls virtual & F2F (at sites, congress, IM)
o Attendance including sites personnel, CRO and Company (PMs, CMLs, MSLs)
o Shares learning opportunity to troubleshoot challenges and streamline workflow. Encourage individual sites to lead discussion on area of expertise.
o Target presentations and publications including site team representatives and advocacy partners present at advocacy and local community organization conferences. Identify appropriate dissemination outlets.
o Disseminate lessons learned back to sites.
o Gather site feedback to help tailor future trainings.
- Individual sites call.
o With either PI or study coordinator to share findings provided, findings provided back to sites through in-person meetings, monthly calls, and tip-sheets.
o Give call- to actions to sites
- Actively contributes to Monthly Newsletters
o Study updates
o Recognize site personnel.
o Disseminate new research.
o Feature new site and/ or personnel.
o Highlight advocacy resources and events that site team can share with patients
- Actively contributes to new sites identification/ feasibility (incl. identifying/reaching to community sites with less competition to have them participating in the study)
- Actively contributes to recruitment boosting initiatives.
o Identifies Vendors responsible for recruitment boosting and actively participate to vendor contract and start up in the study
Qualifications:
- Scientific degree (Pharm.D.; Ph.D; MS…)
- 5-10 years experience in clinical research and clinical sites management in the pharmaceutical industry. Understanding of clinical trials and advanced knowledge of ICH-GCP, Clinical trials regulations, and applicable global and regional/country requirements.
- Decision-making and autonomy: Able to make sound decisions after identification of an issue and being able to make careful consideration of various courses of action towards resolution. Considers the short and long-term impact of those decisions in terms of risk to Company from a regulatory, legal, financial and business acumen perspective. Influencing and motivational skills are needed for tactful and business smart communication with key internal- and external stakeholders.
- Is a team player and understands the roles and responsibilities of various groups managing clinical trials at Company (Clinical, Medical, Medical Affaires, CRO representatives…), engages cross functionally to keep sites, Company and CRO team members engaged around common study goals.
- Fluent in English with excellent communication skills