Clinical Trial Specialist

Clinical Trial Specialist - #1469

Location: Montgomery County Maryland
Full-time - Permanent
(some remote work)

*We offer a $1000 reward for successful referrals. Contact us for details

*We are conducting this search on an exclusive retained search basis

*If relocation is necessary, assistance will be provided

POSITION SUMMARY

Our client company is a well-established clinical-stage T-cell-focused biopharmaceutical company. Their leading drug candidate is uniquely positioned to address key unmet medical needs in immune-oncology and other diseases. They are partnered with industry and academic leaders to investigate combinations with leading immunotherapeutics and to rapidly expand into additional combinations such as CAR-T. They are well-funded and rapidly expanding. We are assisting them in identifying qualified candidates for this position on an exclusive, retained search, basis.

Responsibilities

Provide support for the day-to-day execution of clinical trials following GCP and company’s SOPs. Maintain all trial data logs and ensure accuracy of all study materials and partner with Clinical Project Managers to oversee study conduct.
Plan and track all clinical activity and monitor all trials. Oversee and manage vendors, review contracts/budgets, performance accountability, train vendors on protocol specifications and assess and approve invoices. Be accountable for trial documentation and ensure inspection readiness of respective clinical trial(s) at all times. This includes timely documentation of deviations, creation of story boards or issue summary documents (e.g. for high-risk areas/hot topics.
Work closely with Clinical Scientist/Clinical Lead and other cross-functional team members to develop study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference Binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR), etc.
Ensure an update on pharmacy manual and manage clinical and drug supplies and provide an interface for drug supply forecasts.
Work with clinical operations teams in the review of clinical data including providing guidance on issues/queries as needed and implementing risk management concepts as appropriate.
Be responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory document/packages.
Conduct sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs, and protocol as needed
Collaborate with Clinical Project Managers to create, manage, and report timelines, risk registry, operational logistics and assess study process to ensure all stakeholders are informed and aligned on deliverables
Have a sense of urgency and support overall organizational objectives
Other tasks assigned by the Chief Executive Officer (CEO) or Chief Medical Officer (CMO)

Qualifications:

Experience in management of Oncology trials or pediatric trials preferred

Able to travel domestically (~ 5% or less, not applicable during COVID-19 pandemic)
Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
At least 1-2 years previous experience in study coordination (e.g., study site) or study management (e.g., CRO or sponsor)
Fluency in study phases and demonstrable knowledge of how they apply to clinical development
Strong working knowledge of ICH Good Clinical Practice guidelines
Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management)
Able to handle multiple tasks and deadlines
Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
Possess initiative, excellent attention to detail, able to identify issues and take appropriate actions
Highly effective verbal and written communication skills
Experience using computer applications including spreadsheets, email, word-processing software, and web-based systems
Prior experience with eTMF, CTMS, and EDC systems preferred

Location:

Montgomery County Maryland (some remote work)

Benefits

Benefits include but not limited to: Health insurance (medical paid 100% by company), dental and vision), life insurance, and 401(k) with 1:1 matching up to 3% of the salary and 1:0.5 up to the next 2%.

Interested or have questions?

Please contact Steve Collins via email (Steve@OncologySearch.com) or phone (see contact information below). Should you wish to schedule a conversation with Steve, please visit his call scheduler at: https://calendly.com/steve4/call

Wish to make a confidential referral for this position or our recruiting services? (we offer a $1000 reward for each successful referral. Contact us for details)

There are two methods to make a referral;

Email us and provide contact information for the person you would like us to contact. Your name will not be revealed without our receiving your approval in advance.
Provide our information (i.e. name, website, email address) to the person whom you feel may have an interest. Please ask that person to mention your name when they contact us.

Disclaimer:

NOTE: This is an unofficial document prepared by OncologySearch.com to provide basic information concerning the position. The company we are conducting this search for has the official job description.

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