General Responsibility:
Our mission is to utilize the cutting-edge
science and bring innovative therapies and vaccines for neglected infectious
diseases; a future where patients have access to safe and effective treatment
options, especially in the low- and middle-income countries. We are a small group
of energetic, problem-solvers focused on innovation, and looking to bring
transformative medicines or treating infectious diseases. If you want to make
an impact with your career, while making a difference in other people’s
lives, here is your chance.
The Clinical Operations Manager will support in
executing the study level activities for ongoing and future clinical trials.
He/she is a member of a growing clinical team dedicated to achieving and
exceeding business objectives through efficient execution, high quality and
timely deliverables of all associated aspects of the trial, in compliance with
regulatory requirements and Good Clinical Practice guidelines.
Duties & Responsibilities:
- Responsible for trial management to ensure all
aspects of trials are executed as planned
- Manage and oversee all activities of
contract research organization (CRO)
- Participate in review of contracts (CROs,
sites, etc.)
- Manage clinical site preparation and
validation activities
- Establish and maintain the Trial Master
File (TMF) including essential and non-essential documents. Ensure current
copies of lab certificates, regulatory approvals, research personnel credentials,
etc., are updated in a timely manner and are in compliance.
- Establish relationship with CRO and/or study
site personnel to keep track of patient enrollment and treatment schedules.
Ensure patient follow-ups for clinical results are received in timely manner.
- Ensure the conduct of the study is in
compliance with the currently approved protocol/amendment(s), with current
GCP guidelines and with applicable regulatory requirements.
- Maintain investigational product
accountability and traceability – Ensure product shipped, necessary to meet
study requirements and usage for each enrolling patient per clinical site.
- Manage and support the clinical trial
support team
- Manage clinical trial progress and ensure
completeness of documentation and data collection in adherence with the
project
timelines.
- Verifications of clinical
activities and review of invoices according to the budget
- Reporting status of the trial to senior
management.
- Perform other duties as assigned to ensure
successful management and completion of clinical trial.
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Requirements
Education:
Bachelor's
degree in a clinical, scientific or health-related discipline or equivalent
experience.
Key Attributes (experience, skills and technical knowledge):
• Minimum 3 years’ experience in managing operational
activities of clinical trials is required.
• Previous experience running global trials is
an asset.
• Must have a good working knowledge of
medical terminology and an excellent knowledge of applicable U.S. and
international investigational regulations and guidelines.
• Excellent oral and written communication,
organizational and planning skills.
• Detail-oriented, a self-starter and be
comfortable with broad responsibilities in an entrepreneurial, fast-paced,
small rapidly growing company environment.
• Maintains proper communications with other
departments to ensure communication and good relationships in connection with
matters related to clinical trial projects
• Direct experience in managing a clinical
trial support team, CRO is an asset.
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