Anavex Life Sciences Corp (AVXL)

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Clinical Research Scientist 5+yrs REQ in Pharma or Clinical Drug Dev.
Anavex Life Sciences
Remote•Temporarily remote
Job details

Salary
Up to $140,000 a year
Job Type
Full-time
Temporarily remote (COVID-19)
Qualifications

Bachelor's (Required)
Clinical Trials: 7 years (Required)
Clinical Research or Clinical Scientist: 5 years (Required)
Full Job Description

Clinical Research Scientist – Job Description

Overview:

The Clinical Research Scientist (CRS) position serves a key role within the Clinical Development R&D team, reporting to the Head of Clinical Research Science/Chief Medical Officer. The CRS works closely with the assigned study team(s) and medical director(s) to support the activities associated with one or more clinical studies. This position collaborates

with clinical team members as well as with functions outside of clinical to provide high quality and timely deliverables. The CRS is responsible for achievement of personal goals which support study team, project team, and corporate goals.

Responsibilities:

Lead or support assigned study level activities for 1 or more clinical studies with minimal supervision; may lead or co-lead a study.
Thorough understanding of assigned protocol and protocol requirements.
Support study start-up/conduct/close-out activities as applicable.
Preparation, storage, maintenance of clinical documents.
Protocol development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document).
Performance of medical monitoring duties, under the supervision of medical director(s), depending on the qualifications and experience of the candidate. Should be appropriately trained and fully aware of all aspects of the drug under investigation and the requirements of the protocol, including any annexes and amendments. In order to function as a medical monitor, the candidate should have adequate medical, pharmaceutical, and/or scientific qualifications, and clinical trial experience.
Draft and review of Protocols, Informed Consent Forms (ICF), and related documents; review/support finalization of regional and site ICFs as needed; ensure high quality, appropriate reading level text, and alignment with protocol).
Draft, review, and coordination of Regulatory Documents (e.g., IB, Briefing Books, DSUR, regulatory responses).
Draft, review and validation of clinical study reports; thorough understanding the connection between the data and the clinical study report.
Plan site and CRA training; including logistics, materials and presentations.
Support country/site selection activities.
Collaboration with Clinical Operations for budget preparation, CRO scope of work, etc. (i.e., review and provide feedback on activities/instructions/deliverables related to study data, IVRS, central labs, patient reported outcomes).
Study committee (e.g., DMC) activities such as charters, meetings, presentation preparation.
Investigator Meeting and SIV planning/facilitation/presentation.
Activities related to data generation and validation, including CRF creation, clinical data review, communication as needed to resolve data queries, draft/update/review data review plans, support medical director(s) in data and analyses review (generation of reports, action plans, trend identification).
May support clinical development planning (assist with analysis of data and review of literature to support future planning).
Collaborate with study team members (Clinical/Medical, Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality.
Provide guidance and scientific expertise within team, across department, and across functions.
Lead the planning and preparations for external/stakeholder meetings (e.g., IMs).
Present data/information to external investigators or study staff (e.g., SIV presentations).
Identify and liaise with external partners.
Identify, escalate current/active/future issues; propose and enact solutions.
Education Requirements:

Bachelor’s degree with 7+ years; or PhD/MD/PharmD with 2 years relevant career experience.
Degree in the Life Sciences or significant experience in clinical development ( > 11 years).
5+ years of experience in clinical science, clinical research, or equivalent.
Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
Proficient knowledge and skills to support program specific data review, trend identification, data interpretation.
Knowledge of medical, scientific and clinical research techniques in CNS therapeutic area.
Required Experience and Skills:

Pharmaceutical and/or clinical drug development experience.
Excellent oral (including presentation) and written communication, computer/ database management and project management skills.
Preferred Experience and Skills:

Neuroscience experience, preferably in neurodegenerative or neurodevelopmental disorders.
Ability to effectively communicate and collaborate across functions and job levels.
Ability to assimilate technical information quickly.
Routinely takes initiative.
Detail-oriented.
Strong sense of teamwork; ability to lead team activities.
Proficient in Medical Terminology and medical writing skills.
Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile).