Senior Clinical Trial Manager
Eastridge Workforce Solutions3.9
San Diego, CA
Job description

San Diego, CA

Order: 219160
Order Type : Temporary

Work Location: remote (working on Pacific Standard Time)

Status: Full-Time

Department: Global Clinical Operations

Pay range: $165-170k+


Company Profile


We are a global biotechnology company developing precision, cell-targeting investigational therapies on our propietary platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.


Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.


We are committed to our mission to conquer cancer and aim to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, We have 5 locations in 4 countries, Japan, the Netherlands, and Taiwan.


Position Summary


The Senior Clinical Trial Manager will be a key manager with responsibilities to manage various aspects of clinical trials from study start-up through database lock in coordination with clinical operations leadership. This is an excellent opportunity to join a rapidly growing company to advance novel cutting-edge anticancer therapies into registration trials and later commercialization.


The ideal candidate will have 5-10 years of experience with clinical trial management (including site and CRO/vendor management) with previous experience with oncology (head and neck cancer preferred), combination drug-device studies preferred, and global Phase 2/Phase 3 clinical trial experience. The candidate will have strong working knowledge of drug development process, GCP, ICH guidelines and FDA regulations.


Key Duties and Responsibilities

    Manage operational aspects of clinical trials from study start-up through database lock, with adherence to stated goals, timelines, budgets, and applicable regulatory requirements

    Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements.

    Oversees performance of junior-level clinical operations team members in either a matrix management model and/or as direct reports on their management of study deliverables, and actively provides operational direction and/or general supervision.

    Develop and manage study budget and timelines with clear assumptions

    Track overall spend for the study over the course of the study

    Develop and manage study timelines which includes ability to assess project risks and facilitate appropriate forums with the study team to establish risk mitigation plans.

    Manage study-related vendors including CROs and contract labs

    Serve as point of contact for key vendors and stakeholders

    Responsible for ensuring development and implementation of applicable study plans (i.e., CMP, Communication/Risk Mitigation Plan), protocols/amendments, informed consent templates, eCRF & CRF forms/completion guidelines and site reference manuals/instructions.

    Manage Investigational Product (IP)

    Oversee Co-Monitors to ensure site and vendor compliance (including review of monitoring reports, issue escalation, monitor assessment as monitoring visits)

    Review protocol deviations and data listings as needed to ensure sponsor oversight

    Work cross-functionally to ensure appropriate communication to stakeholders within/across study teams at Rakuten Medical and with vendors

    Review and provide input to vendor contracts, SOWs and assist with invoice reconciliation as needed

    Assist in development of internal SOPs and processes to ensure ongoing compliance and inspection readiness

    Provide frequent study updates to senior management upon request requirements.

    Attention to detail and ability to prioritize tasks to meet critical deadlines

    Able to collaborate effectively with the study team, cross-functional team members, and external partners.

    Support and manage 1-3 clinical studies


Desired Education, Skills and Experience

    Bachelor’s degree or equivalent in the life sciences or related field

    Minimum 5 years related industry experience with large company or 10 years with smaller company

    Experience with global clinical studies

    Experience managing study timelines

    Previous experience with oncology (ideally head and neck cancer) and/or combination drug-device studies is preferred

    Previous experience managing vendor contracts and budgets

    Strong organizational and project management skills, including ability to multitask and

organize/track information

    Strong working knowledge of the drug development process, GCP, ICH guidelines, and FDA

regulations

    Proactive recognition of issues as they arise with resolution and/or appropriate escalation to

management as warranted

    Excellent interpersonal, written, and verbal communication skills

    Ability to work independently and in a team environment

    Detail-oriented

    Strong computer skills and high level of proficiency with Microsoft Office (e.g. Word, Excel,

PowerPoint, MS Project or other timeline management tool, Outlook) and Adobe Acrobat programs

    Ability and willingness to travel at times up to 20% nationally and internationally, depending on trial activities

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.


#LI-DD


Benefits
: Click
here
to learn more about benefits available to Eastridge’s temporary employees. From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.


Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.


We value diverse experiences, including prior contact with the criminal legal system, and applicants with criminal histories are encouraged to apply. Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring, the San Francisco Fair Chance Ordinance, and the Philadelphia Fair Criminal Record Screening Standards Ordinance (a copy of the notice of rights under the Philadelphia Ordinance is available by clicking on this
link
).
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Company details

Headquarters

2385 Northside Dr., Suite 250, San Diego, CA 92108

Employee

201 to 500

Revenue

$100M to $500M (USD)

Industry

Human Resources and Staffing

Company Description
Eastridge, an employee owned company (ESOP), and a leader in the workforce solutions industry offers fully integrated workforce recruitment and management programs delivered through the Eastridge Cloud™ technology platform. Clients appreciate the blend of high touch-service and our intuitive technology, as well as the ability to service all of North America, EMEA, and APAC. Employees are highly engaged with a contagious culture and a well-respected leadership team. Each year we service 1,300 clients, ranging from startups to Fortune 500 companies where an average of 5,000 people work every day. Each of our ten specialized workforce recruitment divisions focuses exclusively on its single discipline, whether you are looking for temporary, temporary-to-hire or direct-hire opportunities. Eastridge Workforce Solutions is committed to the success of our candidates and clients, which is why we are consultative through the entire process from the resume review to offer negotiations. Our partnership continues beyond your new position and into your career. We conduct quality assurance calls on a regular basis to ensure that our service and the opportunity you are placed on exceeds your expectations. Eastridge Workforce Solutions is headquartered in San Diego, California, with regional offices throughout Southern California, Las Vegas, Nevada, Phoenix, Arizona, and the Greater Boston Area, as well as international offices in Mexico, Canada, and London. For more information on Eastridge Workforce Solutions, visit our company website at https://www.eastridge.com/. Eastridge Workforce Solutions is an Equal Opportunity Employer.
Company ratings
  • Overall
    3.9
  • Company & Benefits
    3.4 / 5
  • Culture & Values
    3.8 / 5
  • Career Opportunities
    3.2 / 5
  • Work/Life Balance
    3.8 / 5
  • Senior Management
    3.7 / 5
Company reviews
"Great temp"
Former EmployeeJourneyperson Plumber
Good pay. I had no problems working for the company and they were really great to me have any issues great job placement got hired on with the company I was working for through them

"Discouragement "
Former EmployeeConstruction Administrator
Eastridge found me a great company to work with. But Eastridge never reached out to me to see how I was doing. In the 2 1/2 years I've been with Eastridge, I never got a raise, paid holidays, PTO or bereavement. I worked 5 day 40 hours a week. When my contract ended with the company they found for me they terminated me and did not even try to look for any work to place me. This company doesn't communicate with you at all. You literally have to be rude to get results. You get excuses not results. I would have gave zero stars. They don't care about there staff.

"Estresante y complicado "
Former EmployeeStaffing Associate
La cultura de la oficina de tijuana es estresante

"Very nice folks to be around"
Former EmployeeConstruction Laborer
They helped me through the test that were needed to find out what experience I had and what education I had. I was place at a job site with in 48 hours. And I enjoyed the work where I was placed.