Senior Clinical Trial Manager or Associate Director of Clinical Operations
Company: Faraday Pharmaceuticals, Inc.
Location: Seattle
Posted on: June 24, 2022
Job Description:
Faraday Pharmaceuticals - is a biopharmaceutical company focused
on improving outcomes of critical care and other illnesses by
reducing the loss of cardiac and skeletal muscle function. A major
contributor to decreased quality of life is associated with muscle
loss following illnesses such as a heart attack, emergency health
crises, and other illnesses such as cancer.Our lead therapeutic
candidate, -FDY-5301, is being evaluated for its potential to
minimize damage to cardiac and skeletal muscle and we are studying
patients with Acute Myocardial Infarction (the medical name for a
-heart -attack) and for the prevention and treatment of ICU
Acquired Weakness in major trauma patients.We are also researching
another therapeutic candidate, FDY-8801, which is one of a new
class of anabolic-catabolic transforming agents that we plan to
study in cachexia. Cachexia is a wasting disease that accompanies
cancer and other serious chronic illnesses and is associated with
significant morbidity and mortality.As our Senior Clinical Trial
Manager (Sr. CTM) or Associate Director of Clinical Operations, you
will be primarily responsible for the operational management and
oversight of our global Phase 3 study to assess the effect of
FDY-5301 on cardiovascular mortality and acute heart failure events
in 2,300 subjects with an anterior STEMI (ST segment elevation
myocardial infarction) undergoing primary percutaneous intervention
(angioplasty). You will also help us build our clinical operational
infrastructure and teams. This position reports directly to the
Director of Clinical Operations.You will work closely with the
Medical Monitor and other cross-functional representatives of
Faraday and designated CROs to ensure successful completion of all
clinical study activities and project deliverables within the
required time frame and budget. -You will also provide general
oversight of the CRO and other third-party
vendors.Responsibilities
- As the study lead, partner with the Director of Clinical
Operations on strategy for successful implementation and execution
of the of global phase 3 cardiovascular clinical trial
- Ensure the study is carried out according to the study
protocol, SOPs, and ICH/GCP guidelines/regulations and study
specific manuals and procedures
- Independently and strategically develop and manage the trial's
timelines, study budget, key deliverables, and risk/mitigation
strategies
- Ensure appropriate management and escalation of challenges
regarding of the trial's milestones, metrics, and critical
path.
- Plan and lead study team meetings
- Manage clinical operational staff including hiring, performance
development, training, and mentoring
- Lead the identification and management of CROs and other
third-party study vendors
- Manage and improve performance of third party vendors and field
CRAs to ensure compliance with study protocol and consistency with
scope of work; identify areas of concern and escalate as
appropriate
- Track and ensure optimization of site startup activities and
activation, subject enrollment, data collection, and study
closeout
- Develop site recruitment, enrollment, and engagement
strategies
- Identify, select, and monitor performance of investigational
sites; ensure accurate and timely site visit reports
- Develop and maintain good working relationships with
investigators and study staff
- Negotiate and manage the budgets and payments for investigative
sites
- Lead the development and provide clinical operations expert
input into of trial materials (e.g., protocol, informed consent
forms, case report forms (CRF), CRF completion guidelines,
monitoring guidelines, site initiation visit materials, site tools
and worksheets, product administration guidelines)
- Ensure completeness and inspection readiness of Trial Master
File
- Oversee investigational product release packages and
investigational product accountability
- Perform clinical data review of data listings and summary
tables, including query generation
- Other duties as assignedQualifications -
- Bachelor's degree or equivalent in the life sciences
- At least 8 years of clinical operations experience in the
pharmaceutical industry with significant knowledge of GCP/ICH
guidelines and the clinical development process (Associate Director
requires at least 10 years clinical operations experience)
- At least 2 years of experience managing industry sponsored
pharmaceutical clinical trials as a sponsor employee (experience
managing at least one global Phase 3 trial is highly preferred)
(Associate Director requires at least 3 years' experience managing
industry sponsored trial as a sponsor employee)
- Ability to plan, organize and conduct clinical trials with
minimum oversight
- At least 2 years of experience leading, managing, and mentoring
clinical operational staff and cross-functional teams
- Significant experience managing CROs and other vendors and
assessing performance and finances (e.g., invoice review, change
order management, and budget reforecasting)
- Strong interpersonal, communication (written and verbal), and
prioritizing/organizational skills
- Demonstrated ability to work independently and as part of a
multi-functional study team
- Able to motivate a team to work effectivelyin a changing
environment
- Able to solve problems under pressure
- Self-motivated and able to work effectively in a matrix/team
environment
- Experience and comfort managing and collaborating virtually and
remotely
- Must be willing to travel domestically and internationally
(approximately 20-30%), as needed (when safe to do so in light of
the pandemic)
Keywords: Faraday Pharmaceuticals, Inc., Seattle , Senior Clinical Trial Manager or Associate Director of Clinical Operations, Healthcare , Seattle, Washington
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