What are the responsibilities and job description for the Manager, Clinical Trial Feasibility position at Pinnacle Clinical Research?
Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our patients receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare.
Be a part of the discovery!
Summary: The Pinnacle Clinical Research (PCR) Clinical Trial Feasibility Manager job entails evaluating the viability of clinical trials, identifying potential sites, and ensuring a smooth study start-up, including regulatory compliance and stakeholder engagement. They assess feasibility based on site capabilities, patient recruitment potential, and operational factors, ultimately contributing to successful clinical trials. The Clinical Trial Feasibility Manager will lead and manage the process of clinical project feasibility to support the proposal teams by assisting Business Development with the generation of site network feasibility proposals providing input and advice regarding operational strategy to support client interactions and long-term strategic partnerships. This position is accountable for any recommendations made and assesses their impact on project delivery. It is also responsible for project feasibility assessment and recruitment planning along with supporting business development activities.
Essential Duties and Responsibilities:
Qualifications:
The work environment and physical demands described here are representative of those that must be
met by an employee to successfully perform the essential functions of this job. Reasonable
accommodations may be made to enable individuals with disabilities to perform the essential functions.
Pinnacle Clinical Research provides each of our team members with opportunities for personal and
professional growth in a team-oriented working environment. We offer competitive pay, excellent
benefits, and the chance to grow professionally in the clinical research industry. The salary range for this
position will be commensurate with experience.
employment without regard to race, color, religion, disability, gender, national origin, age, genetic
information, military or veteran status, sexual orientation, gender identity, marital status or any other
protected Federal, State/Province or Local status unrelated to the performance of the work involved.
Be a part of the discovery!
Summary: The Pinnacle Clinical Research (PCR) Clinical Trial Feasibility Manager job entails evaluating the viability of clinical trials, identifying potential sites, and ensuring a smooth study start-up, including regulatory compliance and stakeholder engagement. They assess feasibility based on site capabilities, patient recruitment potential, and operational factors, ultimately contributing to successful clinical trials. The Clinical Trial Feasibility Manager will lead and manage the process of clinical project feasibility to support the proposal teams by assisting Business Development with the generation of site network feasibility proposals providing input and advice regarding operational strategy to support client interactions and long-term strategic partnerships. This position is accountable for any recommendations made and assesses their impact on project delivery. It is also responsible for project feasibility assessment and recruitment planning along with supporting business development activities.
Essential Duties and Responsibilities:
- Conduct appropriate evidence based feasibility to establish the operational viability of proposed projects, through the verification of data relating to i) previous study performance metrics, performed in similar indication/patient population ii) previous feasibility data and iii) Development of external feasibility studies and consultation with internal/ external experts and the wider PCR Investigator community.
- Lead the strategic feasibility and recruitment planning discussion at internal proposal/project kick-off meeting
- Assemble and lead a virtual team during the feasibility and site ID process to collect relevant, high-quality data.
- Develop appropriate site selection and patient recruitment and retention plans, including the management of the site selection process / recruitment plan implementation as required
- Initiate, conduct, coordinate and report feasibility studies with support from operational departments, as appropriate
- Conduct feasibility analysis and prepare detailed client reports
- Document and track feasibility study results for future use.
- Preparation of the feasibility, site selection and patient recruitment plan for the proposal.
- Preparation for and attend bid defense meetings, as required
- Preparation of internal project information to support ad hoc requests for information from clients
- Development of evidence-based material to assist clients with project planning and design initiatives.
- Recognize, exemplify and adhere to PCR’s values and competitive differentiators of People & Culture, Science, and Quality.
- As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
- Line Management responsibility for junior feasibility team members
- Travel (approximately 10-20%) domestic and/or international
Qualifications:
- Educated to at least Bachelor’s degree level or local equivalent.
- A background in medicine, science or other relevant discipline with a substantial experience in clinical drug development across a broad range of therapeutic areas.
- At least 4 years relevant experience in drug development, with some evidence of having conducted with feasibility, recruitment planning, site selection for studies.
- Highly developed planning and organizational skills. Must be able to resolve conflicting priorities to meet tight deadlines.
- Excellent communication, written and oral. The candidate must be able to produce reports to a high standard and review the quality and content of any reports produced by the team. Fluency in English is essential.
- Be an accomplished negotiator with the ability to influence and present to small and large groups.
- Solid clinical operational background with a good commercial awareness
- Competent computer skills including extensive knowledge of literature and internet search.
- Highly developed analytical skills and attention to detail
- Ability to liaise effectively across departments, with senior management, clinical project teams, clients and experts inside and outside PCR.
- A strong team player, with excellent organizational and problem-solving skills and the ability to work independently. The candidate must be able to multi-task and work well within a high pace pressurized environment.
- Demonstrates the ability to use extensive analytical skills to interpret complex clinical data, assess feasibility, and make informed strategic decisions that align with both clinical objectives and business goals.
- Possesses the capacity to lead projects effectively, ensuring that all feasibility assessments, recruitment planning, and site selection processes are conducted efficiently and meet established timelines and quality standards.
- Exhibits excellent written and oral communication skills, capable of producing high-quality reports and presenting complex information clearly to a variety of audiences, from team members to high-level stakeholders.
- Skilled in negotiation, able to engage with and influence both internal and external parties, facilitating discussions and decisions that enhance project outcomes and build strategic relationships.
- Combines a solid understanding of clinical operations with commercial awareness, enabling effective management of clinical projects with an eye towards maximizing both scientific integrity and business potential.
- Proven ability to work effectively across various departments, coordinating with senior management, clinical teams, and external experts to ensure comprehensive feasibility assessments and project alignment.
- Demonstrates the ability to adapt to rapidly changing conditions and overcome challenges in a high-pressure environment, maintaining focus and effectiveness in managing complex clinical trial processes.
The work environment and physical demands described here are representative of those that must be
met by an employee to successfully perform the essential functions of this job. Reasonable
accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license.
Pinnacle Clinical Research provides each of our team members with opportunities for personal and
professional growth in a team-oriented working environment. We offer competitive pay, excellent
benefits, and the chance to grow professionally in the clinical research industry. The salary range for this
position will be commensurate with experience.
- 401k
- Medical, dental, vision, long term disability, short term disability, HSA, and life insurance
- 3 weeks of paid time off
- 14 paid company holidays
- And more!
employment without regard to race, color, religion, disability, gender, national origin, age, genetic
information, military or veteran status, sexual orientation, gender identity, marital status or any other
protected Federal, State/Province or Local status unrelated to the performance of the work involved.