Ref #: 28944

Employment type: Permanent - Full-Time

Location: Canada - Remote

Posted: 13-May-2021

Description

WHO WE ARE:

At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need.

All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you.

Job Description:
GSAM
The GSAM is a member of extended global study team supporting delivery of clinical studies to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.

The GSAM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Project Manager/ Project Leader in delegated aspects of clinical study execution in accordance with the Study Team Operating Model (STOM), Project Management Framework, current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and best practices (e.g. guidelines) and in line with values and behaviours.

PRIMARY RESPONSIBILITIES:
In partnership with enablement team, other clinical experts and external service providers, the PS provides oversight to ensure study delivery.
• Leads/contributes to the preparation of delegated study documents (e.g. Informed
Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.)
• Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives
• Contributes to the planning and conduct of internal and external meetings (e.g.
Investigators’/Monitors’ meeting)
• Ensures the supply of Investigational product and study materials by liaising with Clinical
Supply Chain or external service providers as appropriate
• Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues
• Ensures that all study documents in scope of Project Specialist responsibilities are complete and verified for quality in Trial Master File
• Supports Project Manager / Project Leader with budget management, such as external service provider invoice reconciliation
• Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times
• Supports Project Manager / Project Leader in project management as per agreed delegation
• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

#pmjob

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.