Our Why
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to impact the lives of patients and caregivers every day. At
Early Access Care, our mission is to facilitate investigational medicines to patients without treatment options. If you come from a clinical research background, this job might be an ideal fit – immediate global impact for patients with serious and life- threatening conditions. Our team lives our mission every day. More information about our company can be found at www.earlyaccesscare.com
Job Description
Are you looking for a patient-focused company to inspire you and support your career?
If so, be empowered to take charge of your future at Early Access Care. Join us as an
Senior Clinical Operations Manager in our Madison, CT office reporting to the Clinical
Operations Leadership team.
You will manage the operational activities for requests for compassionate use of investigational drugs from physicians and their staff around the world.
At Early Access Care, you will be a necessary contributor to our inspiring, bold mission.
Goals
Manages the operational activities for requests for compassionate use of investigational drugs from physicians and their staff around the world. Manages essential document collection, including health authority importation authorization, Institutional Review
Board (IRB) and Ethics Committee (IEC) approvals, institution contracts and other essential documents. Collaborates with physician and site staff to conduct compassionate use using Good Clinical Practice (GCP) principles and ensuring accurate data, subject safety and impeccable documentation.
Principle Responsibilities
- Be responsible for the management of compassionate use requests using our IT systems, tools, and expertise to ensure the physician and site staff meet all aspects of local regulatory requirements.
- Be the first contact of the company with the customer (physician, MD), therefore establishes and maintains customer essential relationships.
- Develop, lead, communicate and execute the Early Access (EA) and
Compassionate Use (CU) plans to support EA programs.
- Manage the receipt, assessment, and/or committee review of all requests for
Requests (RIDS)
- Communicate decisions to requesting physicians in a timely manner. If a request for
EA is approved, manage/ support the supply chain, regulatory, drug safety, and legal execution of the request in a timely matter to ensure the patient receives the drug and that ongoing treatment is maintained uninterrupted.
- Operational end to end management of requests for investigational drugs.
- Provide adequate site (Physician and staff) resources for conduct of the compassionate use request.
- Provide proper training Physician and site staff on the compassionate use medication, preparation, storage, administration and safety oversight.
- Provide proper control, storage, dispensation, and accountability of Investigational
Product.
- Ensure site enrollment information is up to date in our IT systems and tools.
- Understanding of Clinical Research industry and the relevant environments in which it operates
- Ability to plan activities and works well under changing circumstances.
- Has some knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of compassionate use.
- Ensure all adverse events (AEs) are appropriately reported within the time periods required the protocol/treatment plan, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s);
- Proactively identify potential issues and assist the project team in the development of site Corrective Action/Preventative Action Plans (CAPAs) if required,
- Works to improve tools and processes within functional area.
- Ability to work as part of a team.
- Strong computer skills
- Good communications, problem-solving, analytical thinking skills
- Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency.
- Developing project management skills
- Ability at analyzing data and information to derive options/recommendations for management considerations.
- Develop and maintain productive and appropriate relationships with individuals across the organization including various expertise areas.
- Ensure that all interactions and activities in the region comply with Early Access
- Care’s guidance’s and policies.
The assigned early access studies may be high complexity, requiring the coordination of multiple vendors, or other special assessments. More than one study or more than one program may be assigned.
Education And Experience
- BS/BA, education required preferably in a health-related, life science area or technology-related field or equivalent combination of education, training, and experience.
- Previous GCP certification is a MUST
- 5+ years' experience in the pharmaceutical industry or clinical research organization, including 4+ years of GLOBAL clinical study management ownership and leadership A MUST.
- Experience must include either early phase clinical studies or Phase 2 and 3 studies and GLOBAL/international studies or programs.
- Experience working in the early access, compassionate use or managed access landscape in the US or Globally is advantageous.
- Experience in more than one therapeutic area is advantageous.
- Knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP.
- Awareness of local country requirements is also required.
- excellence in project management and matrix leadership.
- Excellent communication, presentation and time management skills required.
- Must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization.
- Able to inspire a team to excel by fostering a climate of energy, excitement and personal countability.
- Ability
- of Microsoft Office Suite
- to partner with key internal stakeholders to understand Early Access Care’s key objectives, and to drive plans that exceed these.
- Sense of urgency works collaboratively.
- Fluent in business English.
Travel Requirements
As this is a headquarters-based position it requires very limited travel. This may entail an occasional scientific conference or meeting with sponsor companies or strategic partners.
What Early Access Care Can Offer You
Early Access Care is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, 401(k) with company match, tuition reimbursement, and much more.
The final salary offered for this position may take into account a number of factors including, but not limited to, skills, education, and experience.
This position is currently classified as office based in accordance with Early Access
Care’s Hybrid and Remote Work policy.
Contact Us: Resumes may be sent to Anne B. Cropp anne.cropp@earlyaccesscare.com. No phone calls or recruiters please. This is an office-based position – no remote applicants to apply.
Locations
United States; Connecticut; Madison CT – This is an office site based position.
Worker Type
Employee
Worker Sub-Type
Regular
Time type
Full time
Job Type: Full-time
Pay: $105,000.00 - $150,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
Work Location: In person