Senior Clinical Operations and Safety Support (Oncology Trials) - 1 Year Contract – Hybrid- NC Pharma

Our client, an RTP-area biopharmaceutical company with products in the oncology and severe disease space, is actively recruiting for a highly organized and experienced Clinical Support professional for a 1 year contract on its Clinical Operations Team.   

This company is building and has a solid pipeline with a strong focus in the oncology space.  This role will support Clinical Project Management in managing the day-to-day operational activities, including Safety activities.

It is a key role and company will offer generous wage to attract and retain an excellent candidate.  The select candidate will be instrumental in assisting the clinical team with administrative tasks.

This Clinical Project Assistant will be responsible for supporting the Clinical Project Management function across different compounds and projects.

Key Things to Note:

• This is an established NC-based BioPharma with a growing and impressive pipeline

• This role will support clinical project management as well as clinical safety operations across various projects

• The company outsources to CROs and this role will involve working with CRO partners and vendors, to include tracking safety vendor compliance metrics.

• This is a highly collaborative role involving regular interaction with cross-functional team members, clients and vendor partners.  Right candidate will complement broad and deep knowledge of supporting clinical project teams with strong communication and interpersonal skills.

• This role is Hybrid requiring on-site work at the RTP area office as needed. 

Responsibilities will include:

• Create project specific tracking tools to communicate status on Investigator Initiated Trials

• Schedule meetings, prepare meeting agendas, and author/distribute meeting minutes

• Effectively communicate relevant project information to stakeholders

• Assist with the management of safety vendor to ensure compliance with required timelines, that potential issues are being communicated, and resolution is achieved in a timely manner

• Provide safety CRO with relevant clinical study documents, updates, and contact lists.

• Coordinate the review of safety study plans

• Track safety vendor compliance metrics

• Participate in SAE query management and reconciliation in collaboration with other functional study team members

• Maintain safety distribution and Investigator Initiated Trials (IITs) contact lists

• Perform administrative tasks to support Safety team members, as needed

• Assist in tracking exposure data of IITs.

• Draft status updates for senior staff members across multiple IITs.

• Assist in clinical study documentation filing for IITs.

• Complete draft initial Investigational Product (IP) authorization documentation for IIT sites.

• Communicate to IITs relative to IP expiration updates.

Targeted candidates will offer an Associates or Bachelors degree, to include 5+ years of experience in clinical development supporting a clinical team.  Experience in a Pharma / Biotech / CRO is required.  Experience working with and overseeing CRO partners, including Safety CROs will be a strong plus. 

Other priorities include:

• Working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and Food and Drug Administration (FDA) and/or EU guidelines.

• Experience supporting clinical cross-functional teams will be needed

• Proactive and smart organizational skills

• Excellent communication skills, both oral and written

This is an immediate need.  Please forward Word resume for prompt consideration.