Feasibility Specialist

2 weeks ago

Mississauga, Canada Ergomed Full time

Company Description

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia.

Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

**Job Description**:
The Feasibility Specialist (FS) is a member of the Global Feasibility team within the Study Start Up Business Unit responsible for coordinating and conducting pre-award top-line and post-award contracted feasibility assessments, assessing the viability of planned clinical trials and identification of potential sites for study participation. The FS, individually or together with the local Study Start-Up Specialists, performs site outreach to suitable sites to determine study interest through the completion of a feasibility questionnaire. The FS is under the supervision of the Director, Feasibility.
- Assess the viability of a planned clinical trial in top-line feasibility (pre-award) in collaboration with Director, Feasibility and Medical Team.
- Assess potential study sites in contracted feasibility (post-award) in collaboration with the local SSUSs, Medical Team and Regulatory Team.
- Responsible for creating site list in assigned country/countries for planned feasibility assessment.
- Responsible for site outreach in assigned country/countries; point of contact for site, sharing of non-confidential and confidential study information and management of confidential disclosure agreements.
- Responsible for updating and managing feasibility site tracker and SSU tracker.
- Responsible for filing executed CDAs and completed feasibility questionnaires in Study SharePoint and eTMF.

**Qualifications**:

- Degree in Chemistry or Life Sciences, Nursing or equivalent experience
- Previous experience within the pharmaceutical/CRO industry
- Good knowledge of ICH GCP and national regulations for territories of competency
- Good written and verbal communication skills to clearly and concisely present information
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment

Additional Information

Why Ergomed

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships

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