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Clinical Contracts Administrator (Hybrid)

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Karyopharm Therapeutics Inc.

3mo ago

  • Job
    Full-time
    Junior & Mid Level
  • Legal
  • Newton

AI generated summary

  • You need a B.A. or B.S., 2-3 years in contracts administration, eTMF experience, strong project management skills, and proficiency in MS Office and Adobe Acrobat.
  • You will draft and negotiate CDAs, manage clinical contracts, ensure compliance in contract systems, track expiration dates, support internal teams, and maintain eTMF documents.

Requirements

  • A. or B.S. degree required
  • This role requires a minimum of 2-3 years strong administrative and project management skills as well as the ability to interact with a variety of stakeholders.
  • Solid background as a contracts administrator, ideally in a pharmaceutical and/or biotech industry, with experience working cross functionally with business clients.
  • Experience working with electronic Trial Master File (eTMF) systems for managing clinical trial documents.
  • Ability to prioritize in a fast paced environment on multiple projects with changing priorities.
  • Possess an understanding of global clinical development process and clinical operations – an advantage
  • Ability to work independently with minimal supervision in a team-oriented environment
  • Highly proficient with MS Word, Excel, and Adobe Acrobat. Grant Plan software – preferred

Responsibilities

  • Responsible for drafting, reviewing and negotiating Confidential Disclosure Agreements (CDAs) with US and ex-US healthcare institutions.
  • Support legal team with preparation, management and negotiation of routine U.S. and ex-U.S. clinical contract templates (e.g., drafting amendments, extensions and terminations, interpreting contractual language in response to issues or questions that arise)
  • Serve in an administrative capacity for all clinical contract matters within the legal department (responsible for QC final drafts, execution process, distributing fully executed contracts, monitoring expiration dates of contracts, and contracts filing in accordance with appropriate records retention procedures)
  • Timely tracking, maintenance and updating of company contract management systems to ensure accuracy and compliance with internal procedures and guidelines.
  • Responsible for submitting and maintaining all clinical contract related agreements into eTMF systems. Manage the process for uploading, tracking, and managing department documents in eTMF
  • Work closely with members of the Clinical Operations, Medical, Finance, Compliance and Site Payment teams and other internal clients, as well as external vendors with respect to specific contract request inquiries
  • Ability to follow internal company processes with specific to contracting process guidelines related to contract management systems and department processes; offer and contribute to existing or new department process guidelines to ensure consistencies and improvements
  • Other tasks that may be assigned from time to time to support overall function of legal team

FAQs

What is the role of a Clinical Contracts Administrator?

The Clinical Contracts Administrator is responsible for drafting, reviewing, and negotiating Confidential Disclosure Agreements, managing clinical contract templates, serving as an administrative support for clinical contracts, and ensuring compliance with internal procedures and guidelines.

What educational background is required for this position?

A.B. or B.S. degree is required for this position.

How many years of experience are needed for this role?

A minimum of 2-3 years of strong administrative and project management skills is required for this role.

Is experience in the pharmaceutical or biotech industry preferred?

Yes, a solid background as a contracts administrator in the pharmaceutical and/or biotech industry is preferred.

What software should candidates be proficient in for this position?

Candidates should be highly proficient with MS Word, Excel, and Adobe Acrobat; experience with Grant Plan software is preferred.

What is an eTMF system?

An eTMF system is an electronic Trial Master File used for managing clinical trial documents.

Is the work environment collaborative?

Yes, the role involves working closely with various internal teams and external vendors, indicating a collaborative work environment.

What benefits are offered to team members?

Team members enjoy a comprehensive benefits package including medical, dental, vision, and life insurance, a matching 401k program, generous PTO, wellness programs, and educational reimbursements.

What are the typical working hours for this role?

The job description does not specify typical working hours, but the hybrid format allows flexibility for those working onsite or from home.

What are the career development opportunities at Karyopharm?

Karyopharm offers ample opportunities for learning and taking on new responsibilities, including management development and mentoring programs, along with tuition reimbursement to support professional growth.

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Karyopharm Therapeutics Inc.

Targeting Disease at the Nuclear Pore

Manufacturing & Electronics
Industry
201-500
Employees
2008
Founded Year

Mission & Purpose

Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is an innovation-driven pharmaceutical company dedicated to the discovery, development, and commercialization of novel first-in-class drugs directed against nuclear export and related targets for the treatment of cancer and other major diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s lead compound, XPOVIO® (selinexor), received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2019 in combination with dexamethasone as a treatment for patients with heavily pretreated multiple myeloma. In June 2020, XPOVIO was approved by the FDA as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma. A Marketing Authorization Application for selinexor for patients with heavily pretreated multiple myeloma is also currently under review by the European Medicines Agency. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development.