USA-Scientist III (Scientific)

Company: Artech LLC
Location: Cambridge
Posted on: January 22, 2023

Job Description:

Title: USA-Scientist III
Location: Cambridge, MA, United States
Duration: 12 Months+
-
Job Description:
Hybrid: 2-3 days/week in person, flexibility on days
Preferred Title: Sr. Clinical Scientist

The primary purpose of the Senior Clinical Scientist's position is to assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for the clinical studies, on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to the operational activities from clinical trial set-up to clinical study report in compliance with quality and regulatory processes.

Scope includes all clinical trials for projects in development (excluding studies managed by TMCP) and clinical studies for marketed drugs or devices (e.g., registries), from scientific assessment of a clinical project to final deliverable (clinical study report, clinical part of a CTD, ---)..

Under the guidance of his/her manager in the Therapeutic Area Department, he/she collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers , Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical scientific documents, as needed. He/she ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.

A Senior Clinical Scientist can be assigned to specific tasks with minimal supervision from CRDs (e.g., answering questions from local teams, leading the validation strategy, managing audits or Inspection etc---). He/she can mentor and accompany junior associates, clinical scientists, or clinical research directors. He/she can ensure operational and scientific consistency at project-related activities across studies or support submission of the CTD activities.
Knowledge and Skills:
--- Scientific expertise or interest and ability to learn in the domain of assigned study/project.
--- Well organized, high level of autonomy and motivation
--- Strong leadership is required, as the clinical scientist may have to act as a CRD, or take decisions on his/her behalf
--- Quality focused, able to develop good practices, using a critical data-driven and risk management approach
--- Familiar with digital tools such as data analytics or agility to use them
--- Strong communication skills (verbal and written)
--- Multiple tasks handling and prioritization
--- Ability to analyze and interpret data-driven decision dashboards
--- Ability to synthesize the information, good presentation skills
--- Excellent decision-making and problem-solving capabilities,
--- Capability to challenge decision and status quo
--- Ability to work autonomously and to efficiently provide status reports
--- Ability to anticipate and timely escalate issues and to define appropriate action plans
--- Team and results oriented
--- Teaching skills, ability to mentor and train others
--- Experience of working internationally with Strong English skills (verbal and written if English is not the native language)
--- Ph.D., Pharm.D., or similar; bachelor's degree considered for candidates with experience. Previous experience in Clinical Research and/or Clinical Drug Development (e.g., at least 10 years within pharma industry, academic research or CRO).
--- Knowledge in ICH, GCP.
--- Fluent in English.
Knowledge And Skills Desirable But Not Essential:
Statistical, data management and regulatory knowledge.


(in order of importance.)
MAJOR DUTIES & RESPONSIBILITIES: Briefly describe the major duties and responsibilities for which the job is held accountable (what the job does, why is it done/impact)

1. Contributes to preparation and/or review of any documents related to the studies and requiring a scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations/communication to internal or external partners, study reports, committee charters, protocol registration form, redacted protocol, Client summary---)
2. Supports CRD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project
3. Contributes to the definition of the critical data/processes/predefined deviations list, risks and Quality tolerance limits identification and monitoring, to implement/develop related sections of the study risk management plan
4. Is involved in the update of study documents, eCRF adequacy with protocols/protocol amendments and helps in rationalizing and documenting the data collection needs quantitatively and qualitatively and decreasing the complexity
5. Develops study specific training material and participates in the Investigators, Study Team, and monitoring team training on medical information
6. Contributes to definition of the centralized monitoring strategy in consistency with the planned statistical analyses and is involved in study data validation and review processes, supports the CRD for the Clinical Case review (safety events reported to GPV or adverse events of special interest), notably to anticipate and prevent last minute queries or backlog and smoothen the process.
7. Supports CRD in implementing, managing, organizing, and conducting Steering committees, Data Monitoring Committees, Adjudication Committee meetings
8. Supports regulatory documents filing and archiving
9. As appropriate and not limited to, contribution to and review of study plans, study reports, briefing package, Investigator brochure (IB), Development Safety Update Report (DSUR), clinical parts of submission dossier, publications for accuracy with clinical study report as well as ensuring completeness of study reports appendices under the responsibility of the CRD
10. Train/mentor newcomers, clinical scientists or clinical research directors on operational activities related to project support

Keywords: Artech LLC, Cambridge , USA-Scientist III (Scientific), Other , Cambridge, Massachusetts