Senior Clinical Project Manager, Clinical Operations Study Management
- Job Type: Full-Time
- Function: Clinical Research
- Industry: Biotechnology
- Post Date: 11/20/2023
- Website: eikontx.com
- Company Address: 3929 Point Eden Way, Hayward, CA 94545
About Eikon TherapeuticsEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the interface of biology, engineering and chemistry to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells.
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
The Senior Clinical Project Manager, Clinical Operations Study Management will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require onsite presence a minimum of 3 days a week to ensure effective management of assigned Phase I-III in-sourced global clinical studies. The successful candidate will work closely with cross-functional teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support excellence and world class clinical study management.
You are a talented, experienced, growth minded individual, and have a passion for excellence in advancing patient care and driving strategic operating priorities.
What You’ll Do
- Team leader and builder, who manages trial deliverables, timelines in assigned protocols to meet country commitments
- Responsible for quality and compliance in assigned protocols
- Works with minimal oversight from Clinical Operations Senior Director or Director, in collaboration with Clinical Operations teams, and Clinical Research and Development functional teams
- Works with finance, legal, external vendors and clinical sites to ensure country deliverables are obtained for submissions, budgets, regulatory and local milestones
- Collaborates closely with Regulatory and Clinical Operations to align on country timelines
- Provides support and oversight to local vendors as applicable
- Oversight and coordination of local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements (in collaboration with TMF Operations team), insurance process management
- Enter and update country information in clinical, regulatory, safety and finance systems
- Contribute or lead initiatives and projects adding value to the enterprise, as required
- Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines.
- Bachelor's degree
- At least 8 years of experience in effectively running global clinical studies (prior oncology clinical trial experience is preferred)
- In-depth knowledge of ICH-GCP, EMEA guidelines and other relevant regulations and guidelines.
- Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety
- Ability to proactively develop risk management and mitigation plans in country and resolve issues locally
- Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills
- High sense of accountability and urgency in order to prioritize deliverables
- Strong communication skills and negotiation skills as well as excellent influencing and training/mentoring, both written and verbal
- Ability to focus on multiple deliverables and protocols simultaneously is essential
- Positive mindset, growth mindset, capable of working independently and being self-driven
- Able to directly influence Clinical Operations staff.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
- 401k plan with company matching
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
- Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
The expected salary range for this role is $134,000 to $154,000 depending on skills, competency, and the market demand for your expertise
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.