Participates in development of the Clinical Development (CD) strategy and plan and supports the assigned Medical Director/AD with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s)/indication(s).
Support Medical Director/AD with clinical documentation, representing CD on various sub-teams or other appropriate forums, supporting training of study site personnel, acting as a primary point-of-contact for questions and inquiries to CD regarding CD studies or other programs, conducting ongoing medical/safety data reviews, and providing clinical science inputs into study reporting.
Responsibilities
Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, and KOLs, as well as multidisciplinary internal groups, including research, business development, legal, etc.
Expected to make important contributions to the CD strategy for the relevant therapeutic/disease area(s)
Develops the CD plan with the Medical Director/AD for assigned molecule(s)/indication(s) and/or other programs Gathers and analyzes data and information necessary to create the CD plan.
Where applicable and assigned, supports Medical Director/AD in providing other groups with information and input into budget/resource requirements necessary to implement and execute the CD plan
Supervise, develop and mentor Associate CRP/CRP as assigned by clinical project leader
Provides strategic clinical science support for assigned studies and programs:
Develops clinical study designs for review and discussion with Medical Director/AD.
Conducts appropriate literature searches.
Collaborates with clinical operations, other groups and Medical Director/AD/Principle CRP/Senior CRP to develop Informed Consent Form (ICF), protocol, Case Report Forms (CRFs), CRF instructions, etc.
Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation managed by other Hutchison groups.
As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with Medical Director/AD/Principle CRP/Senior CRP (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
Collaborates with clinical operations to develop agendas, materials and other items for investigator and other relevant meetings pertaining to assigned studies and programs
As needed/appropriate, accompanies clinical operations staff to study site visits, investigator and other meetings
Provides additional support with site training, as needed, or requested
Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.
Collaborates with Medical Director/AD/Principle CRP/Senior CRP, clinical operations, data management and other groups to conduct medical review of study data; identifying and evaluating study data trends, outliers, protocol violators, etc. Works with Medical Director/AD/Principle CRP/Senior CRP, clinical operations, data management and potentially other groups to develop and communicate relevant medical inquiries
Tracks items for inclusion in protocol/ICF amendments and works with other groups to ensure the timely and appropriate completion of protocol amendments
Assists Medical Director/AD/Principle CRP/Senior CRP in responding to HA inquiries
Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders. Coordinates submissions to scientific meetings and/or other appropriate venues or groups
Be responsible for CRA team management and operational management system.
Oversees the performance of the CRAs within their specified team. Implements professional development and performance evaluations;
Ensures that clinical monitoring activities of their assigned team are performed to the project’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements;
Supports the training and development of clinical monitoring personnel within their remit and ensures team members’ consistent use of study tools and training materials;
Tracks clinical monitoring metrics such number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings;
Performs on-site Accompanied Site Visits with CRAs;
Identifies quality issues related to clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, Accompanied Site Visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions;
Serves as a point of contact for CRAs and other team members for assigned projects or initiatives;
Assists with assessing and interviewing potential clinical monitoring candidates;
May conduct on-site monitoring visits to offer support to project teams;
May perform site visit report review and track site visit report metrics to ensure compliance;
May review and provide feedback on related SOPs and TOOLs during updates;
Serves as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.
Qualifications
Education:
Sc. in a field relevant to clinical research
Experience:
Minimum of 10 years of experience in clinical research in the biotechnology, pharmaceutical, or CRO industry
Knowledge and skills:
Excellent oral and written English skills.
Excellent line management skills
Strong knowledge of ICH/GCP standards and applicable regulatory requirements;
Quick learner, good adaptability and versatile;
Excellent leadership, judgement and problem-solving skills;
Strong organizational, communication, time management and multi-tasking skills;