Download Clinical Study Manager Reference 16

Clinical Study Manager
Reference 16-39
Posted: November, 2016
About us:
At Arbutus we have a vision: to cure chronic Hepatitis B virus (HBV). We have a dedicated and
innovative team and we are uniquely positioned to transform the HBV treatment landscape. We are
developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in
a combination therapy to cure HBV. Arbutus Biopharma has offices and research facilities in Burnaby,
Canada and Doylestown, Pennsylvania, USA.
About the role:
Arbutus has an opportunity for a driven and independent Clinical Study Manager to join our team in the
East Coast. Reporting to the Director, Clinical Operations, the Clinical Study Manager oversees the design,
planning, implementation and monitoring of assigned Clinical Studies. This position will be located either in
our Pennsylvania office, or in a well-situated home-office with the ability to travel as required to Arbutus’
offices.
If you are looking to join a team with a proven track record in drug discovery and development, and are as
passionate as we are, we want to hear from you.
Responsibilities will include:
 Manages and coordinates all aspects of assigned trials to ensure they are conducted in accordance
with established protocols, Company standards and ICH/GCP guidelines;
 Responsible for all financial aspects of assigned studies, ensuring competitive costing and ongoing
cost control including budgeting, tracking of actual spending and mitigating financial issues as they
present;
 Develops and tracks study budgets and timelines to meet all milestones. Monitors all study activities
and results taking/recommending corrective action to ensure that all assigned studies are
completed on time and on budget;
 Works closely with finance department to ensure appropriate financial accruals and reporting of
actuals. Integrates financial information (budgets/actuals) with Project Management team to
ensure effective project tracking;
 Assists in the design and writing of clinical protocols for assigned projects;
 Tracks and reports on study metrics and keeps abreast of study developments;
 Identifies and recommends vendors and oversees contracting process in order to ensure study
requirements are met;
 Coordinates CRO and vendor contracting process and manages CRO’s and vendors to ensure stated
objectives and deliverables are met;
 Provides assistance to Regulatory Affairs as necessary for filing and other necessary compliance
requirements;
 Collects and reviews clinical data and results and ensures reports and summary data are prepared
and disseminated appropriately;
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Determines information and reporting requirements for assigned studies designing forms and
procedures, as necessary;
Other related duties as assigned.
Qualifications:
 BSc in a related Life Sciences Discipline, Master’s degree preferred, with a minimum of 5 years’
experience in a senior clinical operations role or an equivalent combination of education and
experience.
 Must have direct experience overseeing clinical studies in the biotech/pharmaceutical industry.
 Excellent ability to track and organize clinical trials.
 Experience with data analysis, report and protocol writing.
 Ability to work effectively independently and as part of a team.
 Comfortable managing multiple projects and ability to adapt to changing priorities.
 Excellent knowledge and ability with MS Office software; advanced user level in MS Word, Excel
and Power Point.
 Strong understanding of Clinical Development.
 Proven project management skills including budgeting, scheduling, risk management and project
tracking.
Contact Information:
3805 Old Easton Road
Doylestown, PA 18902
e-mail: [email protected]
web: arbutusbio.com
How to Apply:
We invite you to send your cover letter and resume in PDF format, to [email protected]. Please
ensure your submission is in PDF format (ideally in one document) indicating your surname in the
filename (for example: SmithJane-cover-CV.pdf) and position title and reference number in the
subject line of the email (“Clinical Study Manager [reference #16-39]”).
About your Application:
At Arbutus we value diversity and encourage applications from all qualified candidates.
We greatly appreciate your interest in being a part of our team; however, because of the volume of
resumes received, we are only able to contact you should you be considered for a position. We will keep
your resume in our database for one year, and contact you should a position that matches your skills
become available.