Pre-award Feasibility Manager

5 months ago

Ottawa, 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**:
As a Pre-Award Feasibility Manager, you will play a crucial role in assessing the viability of potential clinical trials and projects before they are awarded to the organization. The role will directly impact the successful initiation and execution of clinical trials, ensuring full awareness of how the protocol aligns with global standards of care, clinician interest, and the patient experience. Leveraging your expertise in clinical research, project management, and feasibility assessment, you will contribute to the strategic decision-making process by evaluating the viability and potential challenges associated with new projects. Collaborating with cross-functional teams, you will provide valuable insights that guide the organization's pursuit of successful projects and ensure alignment with strategic goals.

**Role and Responsibilities**
- Analyze trial protocols, study designs, and other project details to determine feasibility within the organization's capabilities.
- Evaluate potential risks, challenges, and constraints associated with proposed projects.
- Partner with business development and/or clients to understand sponsor needs, as well as to align with project proposals and trial requirements.
- Synergize with the Data Intelligence and Patient Engagement functions to ensure that the summary feasibility assessment is asking the most relevant questions, and is interacting with the most relevant clinicians, patients, advocates, etc.
- Engage closely with Medical Affairs to facilitate rapid outreach to Key Opinion Leaders in relevant geographic regions, so as to build as comprehensive a summary feasibility report as possible within tight time constraints.
- Interact with cross-functional operational teams, including clinical operations, regulatory affairs, project management (and others as necessary) to gather input and insights for summary feasibility assessments.
- Collaborate with key external and internal resources to document the global/local standards of clinical care, assess clinician alignment and interest in the protocol design & therapy, and evaluate the relevance of the endpoints being measured.
- Research and analyze the current market trends, competitive landscape, and therapeutic area dynamics relevant to each proposed project.
- Provide insights on potential patient recruitment challenges, site selection considerations, and regulatory implications.
- Compile summary feasibility reports as quickly as diligence will permit, which outline the assessment findings, risk factors, and potential mitigation strategies.
- Present summary feasibility reports to internal stakeholders and clients, communicating effectively to convey the assessment results and recommendations.
- Liaise with the project initiation team to ensure a smooth transition from summary feasibility assessment to project initiation, as well as potentially a full (billable feasibility evaluation) ensuring that all relevant information is communicated effectively.
- Contribute to the improvement of internal processes and tools used in feasibility evaluation.

**Qualifications**:

- Bachelor's degree in life sciences, pharmacy, clinical research, or a related field
- Proven experience in clinical research within the pharmaceutical or CRO industry.
- Proven experience in conducting feasibility studies.
- Strong analytical skills with the ability to synthesize complex information and provide actionable insights.
- Excellent communication and presentation skills, with the ability to convey complex ideas to stakeholder (both internally and externally).
- Strong understanding of clinical trial design, protocols, and regulatory requirements.

Additional Information

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 care

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