Temp bCALM IDMC Specialist

Pay Range: $48.08 - $57.69/hr

Onsite Role in Armonk, NY

12 Month Contract

The Business Contract Administration and Lifecycle Management (bCALM) IDMC Specialist is a dynamic and proactive position. This role is responsible for directly managing bCALM IDMC contracting and oversight activities, which are essential for the establishment and ongoing support of clinical study IDMCs. Acting as an IDMC contracting delegate, the Specialist collaborates closely with clinical study teams and internal support functions on behalf of clinical study Medical Directors to ensure the successful execution and maintenance of IDMC contracts for their assigned Therapeutic Area / CDU.

This role must sit onsite 4-days per week, and is not eligible remote.

A typical day in this role looks like:

Independently manage assigned areas of responsibility, ensuring continuous and active engagement to proactively assess and resolve stakeholder needs.

Cultivate and sustain strong business relationships with internal support functions engaged in the IDMC contracting process to support efficient and timely interactions and contract progression.

Monitor IDMC progression for assigned areas to ensure that payments are processed timely for HCPs and related third-party vendors.

Prepares Conflict of Interest (COI) Disclosure Form for distribution to each potential IDMC member.

Requests Confidentiality Disclosure Agreement(s) (CDA) from the Transactions Law Group Legal Representative via the Law Group’s contract management system.

Provides R&D Legal Representative with IDMC member business and financial information (including the FMV rate for each member), and study-related information for preparation of IDMC consulting agreement(s)

Sends IDMC consulting agreements to IDMC members for their review and approval.

Manages the signature process for IDMC consulting agreements and forwards them to the R&D Legal Representative.

Notifies key functional area representatives (e.g., Study Biostatistician, Data Management Lead, Clinical Scientist, Study Medical Director) that fully executed IDMC consulting agreements have been received.

Initiates  contracting process for SDAC vendor with representatives with Global Procurement and VRM. This vendor will support the Biostatistician in managing the respective IDMC.

This role may be for you if you have:

• Strong understanding of the contract management lifecycle
• Strong understanding of clinical development operations, with prior experience progressing IDMC member contracts, including external non-HCP vendors
• Strong desire to learn and assume new areas of responsibility
• Confidence in independently managing tasks to successfully achieve business objectives.
• Comfortable engaging with external HCP and Non-HCP providers and all levels of internal stakeholders, including senior leaders.
• Strong ability to execute and achieve assigned business outcomes
• Proficient in communicating and articulating ideas effectively
• Strong written and verbal communication skills
• Excellent analytical and problem-solving skills.
• Budgeting and forecasting fundamental skills
• Detail orientation with project management skills.
• Pharmaceutical / Biotechnology / Life Sciences experience preferred, prior direct clinical trial support ideal.

In order to be considered qualified for this role, a minimum of a Bachelor's degree in business / management related field preferred and 3+ years of relevant experience.

• 2+ years of experience in a business operations, procurement, or contract administration role
• 2+ years experience supporting Clinical Trial teams

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation