Position: Clinical Operations Manager
Status: Full Time Position
Reports to: Chief Executive Officer
Location: Downingtown, PA Office or remote with appropriate experience
Supervisory Responsibilities: N/A
Travel: Must be willing to travel (domestic and international) and work occasional weekends.
How to Apply: Email a cover letter and resume to Cory.Mcginley@trgconsutlants.com. Include “Clinical Operations Manager” in the subject.
Organizational Information:
The Friedreich’s Ataxia Research Alliance (FARA) is a national 501(c)(3) non-profit organization dedicated to the pursuit of scientific research leading to treatments and a cure for Friedreich’s ataxia (FA).
We are a mission-driven, collaborative community dedicated to supporting the advancement of research that drives the development of treatments for people living with FA. Our compassionate team understands that at the heart of every research grant, clinical trial, and scientific breakthrough are individuals and families living with FA whose strength inspires everything we do. Together, we fund and facilitate research to slow, stop, reverse, and cure FA.
Position Summary:
The Clinical Operations Manager will lead clinical operations for observational studies funded by FARA and carried out through the academically led, Friedreich’s Ataxia Global Clinical Consortium (FA-GCC). The FA-GCC, includes >30 clinical research sites, and primary study is a natural history study, UNIFAI, with about 3000 participants enrolled. The FA-GCC and UNIFAI study are essential resources as they advance our understanding of Friedreich’s ataxia, enable innovative clinical trials, provide a platform for broad stakeholder collaboration, and empower the FA academic and clinical community. The Clinical Operations Manager holds responsibility for all operations of FA-GCC led clinical research including protocol execution and refinement, database management, legal and regulatory compliance across domestic and international sites, site training and monitoring, budget and financial operations and communications with all stakeholders (researchers, clinicians, coordinators, international research advocacy partners, biopharma, funding partners, patient families, and government partners).
The successful candidate will have clinical research and operations management experience, strong leadership and interpersonal skills, understanding of research consortia and professional experience working with academia and pharma/biotech.
Professional Experience Requirements:
- Master’s degree and/or equivalent professional experience
- 5-7 years of clinical research and/or clinical operations experience including project management for multi-site studies
- Experience in managing global studies across multiple countries and familiarity with General Data Protection Regulation (GDPR) requirements and implications
- Ability to lead diverse group of research and healthcare professionals
- Ability to establish productive relationships with stakeholders to deliver goals of the FA-GCC and FARA mission
- Scientific/research acumen
Skills Requirements:
- Electronic Data Capture (EDC) system management experience, preferred
- Budgeting and financial management experience, preferred
- Contracting experience, desirable
- Strong written and verbal communication skills
- Managing stakeholder expectations
- Time management and organizational skills
- Proficient with a variety of software programs including client relationship management (e.g., Microsoft Office – Word, Excel, PowerPoint, Publisher and Adobe Acrobat), Microsoft 365/Teams, Video Conferencing Platforms
- Demonstrated agility and ability to make adaptations to working methods as necessary and applicable
- Knowledge of Friedreich’s ataxia (FA) or other neuromuscular diseases, strongly preferred but not required
Essential Responsibilities:
Lead operations for the Friedreich Ataxia Global Clinical Consortium
- Ensure that scientific and strategic goals of the FA-GCC and the UNIFAI study have the necessary infrastructure, operational support and oversight for success including data collection and management, site operations, legal and regulatory compliance, and financial reporting.
- Execute clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and FARA’s policies and procedures)
- Work in close collaboration with finance team to ensure accuracy of financial reports for sites and studies.
- Oversee database management, monitoring and effectiveness, identifying changes, providing oversight of new database builds sub-studies as applicable.
- Manage external vendors providing database and statistical analysis support, regulatory compliance expertise, and other professional services as applicable.
- Provide project management support to the FA-GCC steering committee, core scientific team and working groups, including scheduling, agendas, meeting minutes, and request tracking.
- Identify and implement opportunities for FA-GCC to support and advance FARA’s mission in partnership with appropriate stakeholders.
- Empower the FA academic and clinical community to present more unified perspectives to biopharma and play a larger scientific role in trial protocols and the patient-selection process.
- Balance the priorities of a diverse group of stakeholders from across the world.
Work with FARA scientific and leadership team
- Working with FARA’s CEO, ensure that the FA-GCC is integrated in the organization’s strategic and financial plans, specifically being the domain resource that brings greater efficiency and effectiveness to clinical development for all therapeutic approaches.
- Coordinate with FARA’s Director of Global Relations to understand opportunities and challenges of the greater global FA community, identify opportunities for the FA-GCC to engage new stakeholders and bridge gaps in clinical research.
- Provide executive level reporting to FARA’s Board and engage FARA directors and advisors to ensure the continued success of the FA-GCC.
- Ensure accurate, timely and clear communications with all stakeholders. Follow established organizational policies and procedures and compile information and reports as required.
- Provide first-rate customer service as front-line stakeholder contact.
- Attention to detail demonstrating accuracy and efficiency in creating and delivering organizational documents, protocols, standard operating procedures, presentations, and documentation of business correspondence.
FARA is an Equal Opportunity Employer. FARA shall not discriminate because of race, color, age, sex, disability, genetic information, national origin or ancestry, religion or any other protected characteristic.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
If employed by FARA, employees agree to accept and certify to abide by both FARA’s Child Safekeeping Policy and FARA’s Code of Conduct at www.curefa.org/mission under the Policies and Disclosures tab.
FARA offers competitive benefits including medical, dental, life, long-term disability and paid family and medical leave benefits, plus a 401K retirement plan. Salary range $95,000.00- $120,000.00 commensurate with experience.
FARA is committed to safeguarding your privacy and data rights. You can read the FARA Privacy Policy for more information: https://www.curefa.org/privacy-policy/