Opportunity DetailsOn Assignment
Clinical ScientistRemote USA
Job SummaryThe Clinical Development Scientist is responsible for the execution of the deliverables necessary for effective and efficient execution Clinical Development (CD) plan for all studies/projects that he/she is responsible for. This role has primary responsibility for the development of clinical study design, writing various clinical documents such as, but not limited to, clinical study synopsis, clinical study protocol, investigator brochures etc.
The Clinical Development Scientist will be a part of the study specific sub-teams, acting as a primary point-of-contact for questions and inquiries to the study protocol and contents within. This role is likely to join in regular interactions with clinical sites/Investigators, external vendors, Clinical Operations/Data Management/Biostats colleagues in support of the clinical study execution and timely identification & escalation of potential issues/concerns. The Clinical Development Scientist will also work closely with the project management team and will be responsible for overall tracking of projects/departmental activities and provide timely updates to the Indication Lead.
Accountability & ResponsibilitiesClinical Lead
- Lead development of study designs.
- Lead writing of protocols, and amendments, ICFs, and clinical sections of other documents.
- Lead clinical study data review and interpretations
- Lead the preparation and presentation of clinical study data at management meetings.
- Track and update the CD deliverables across all clinical studies responsible.
- Regular maintenance and update of the CD project folders/drives.
Clinical Study Planning Development, Data and Reports
- Author study documents such as Protocol Synopses, Protocols, Protocol amendments, Administrative Change letters etc.
- Ensure trial implementation according to the Study protocol.
- Author and timely review of trial-related documents such as the IBs, ICF, CRFs, CRF Completion Guidelines, Study Execution and Monitoring Plans, Clinical Data Review Plan, Clinical Database specifications, statistical analysis plan, the data management plan, the medical monitoring plan, Clinical Study Report (CSR) etc.
- Regular and ad-hoc data reviews and interpretation; prepare and present summaries/documentations of these reviews to Indication Lead and Senior Director/Director, clinical development.
- Support the development of program-level documents, including, but not limited to, abstract and manuscripts, presentations, and various other internal and external documents and communications as needed.
- Assist in the review of clinical study entries (clinical trial information and results) for posting to the Endo CTRR (Clinical Trial Registry and Results) database/TPR (Third Party Registry)
- Support identifying, contracting and engaging subject matter experts/thought leaders in advisory board meetings, consultancy etc.
Clinical Operations
- Participation in vendor selection process, specification development, and management/oversight, as needed.
- Develop/coordinate study specific training materials for study team, investigational sites, and vendors.
- Ensure CD participation and presentations at Investigator meetings or similar.
- Oversee & guide Clinical Development Scientists with scientific and data-related queries.
Safety & Efficacy
- Ensure collaboration between Clinical Development Scientists and Clinical Safety Scientists & PVRM for identifying trial-related safety trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.
- Ensure collaboration between Clinical Development Scientists and statisticians to identify any trial-related efficacy trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.
QualificationsEducation & Experience - Advanced Scientific degree (PhD/PharmD/Masters degree)
- At least 5 years of experience in clinical development within Industry (pharmaceutical, CRO)
- Previous experience designing and developing phase 1-4 protocols.
- Good therapeutic area experience (typically demonstrable with 2 or more years relevant experience).
- Good experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.).
- Data listing review experience.
- Experience working on a clinical team.
- Previous project management/clinical operations experience desirable
Knowledge- Has good knowledge of clinical research and has successfully worked across Phase I - IV drug development projects.
- Comprehensive understanding of product and safety profiles.
- Well-versed in medical aspects of GCP, ICH, FDA, EMEA, and other relevant guidelines and regulations.
