Job Description - Study Start-Up Specialist II (Client Based - Montreal) (20003297)
Study Start-Up Specialist II (Client Based - Montreal)-(20003297)
assigned activities within the country that lead to start-up of investigative
sites in all phases of clinical trials. Responsible
for the delivery, with oversight from the SSU Country Manager in one or more of
the following functional areas: investigator site contracts, ethics and
regulatory submissions, and of essential documents required for site
initiation. Ensures local activities are
undertaken in accordance with agreed timelines, allocated budgets, and required
quality standards. Ensures an efficient
start-up process on assigned studies.
May act as main contact with Regulatory Authorities (RA) and Central/Regional
Ethics Committees (ECs).Under the supervision of the Project Lead (PL) or Site
Start-up Lead (SSUL) as appropriate, may directly interact with Customers
regarding requirements from RA or other local regulatory party. Accountable to
the PL/SSUL at the project level and line manager for deliverables.
– Responsible for providing quality on deliverables at the country level and
follows project requirements and applicable country rules, with oversight from
the SSU Country Manager.
within the forecasted submission/approval timelines and ensures they are
complied with and tracks milestone progress in agreed upon SSU tracking system
in real time; if forecasted timelines are not reached provides clear rationale
for delays, assists with contingency plan to mitigate impact, and escalates the
issue as soon as identified.
basic financial aspects of the project and the number of hours/tasks available
per contract; escalates discrepancies in a timely fashion.
and complies with Standard Operating Procedures (SOPs) and Work Instructions
(WIs) in a timely manner, keeps training records updated accordingly and
ensures timesheet compliance.
all relevant documents are submitted to the Trial Master File (TMF) as per Company
for one or more of the following functions at the country level:
Submissions Specialist - Follows the project direction provided by the
designated country start-up advisor (CSA) and SSUL. May serve as a point of contact for the
SSUL/PM (or designee) during start-up on allocated projects. Compiles and/or reviews essential document
packages for site activation and may also be involved in essential document
collection from site.
and submits Central EC Applications, Local EC Applications, RA Applications,
and other local regulatory authorities or hospital approval submissions as
required and under supervision. Prepares
ongoing submissions, amendments, and periodic notifications required by central
and local EC and RA, and other local regulatory authorities as needed within
the country; includes safety notifications as required by local rules, with
overight from the SSU Country Manager.
Local Site ID and Feasibility Support – Provides support with site
selection lead and PM/SSUL to ensure that the appropriate sites are selected
for individual studies based on the requirements of the clinical trial.
Investigator Contract and Budget Negotiator – Supports the SSUL to agree on
country template contract and budget. Assists
in producing site-specific contracts from country template. Under supervision assist in negotiations of budget
and contract with site and via Site Contracts Service Centre and SSUL lead with
Sponsor until resolution of issues and contract execution. Assists with quality control and arranges execution
of CTAs as well as archival of documents into repositories and capture of
QUALIFICATION & REQUIREMENTS
(please indicate if ‘preferred’)
Associate’s Degree or equivalent combination of
education and training.
Good understanding of clinical trial process across
Phases II-IV and ICH GCP, Ability to interact effectively and appropriately
with investigative site personnel.
Good organizational skills and good attention to
detail, with proven ability to handle multiple tasks effectively.
Ability to take direction from multiple individuals
and set priorities accordingly.
Ability to effectively communicate across multiple
function groups (clinical team, PM, Director).
Demonstrated ability to work independently, as well
as part of a team. Utilize problem-solving techniques effectively.
Quality-driven in all managed activities.
Flexibility and willingness to adapt to rapidly
changing environment and learn/perform new functions.
Strong computer skills, including Word, Excel,
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