USA-Scientist III (Scientific)
Company: Artech LLC
Location: Cambridge
Posted on: January 22, 2023
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Job Description:
Title: USA-Scientist III
Location: Cambridge, MA, United States
Duration: 12 Months+
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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
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