Marta Biggs Email & Phone Number

Writing and negotiating contracts for medical device company’s new product clinical studies (both feasibility and labeling and 510K studies including clinical study agreements, NDAs, consulting agreements; RFP preparation (in conjunction with clinical associates) and negotiation of resulting offers for selected CROs. Contract preparation, negotiation and project management of investigator- sponsored research studies. Inlcudes redesign and rewriting of standard contract templates to include new HIPAA and PHI regulations and company policy revisions. Preparation and negotiation of Asian, Indian, and Euro-Alliance countries research contracts using templates at the direction of company’s EU attorneys. Preparation and negotiation of educational grants and charitable contributions documents.

Write and negotiate budget terms and conditions for large multiple site clinical studies. Prepare and track final contracts and manage site pnd patient payments for clinical study sites based on budget milestones for Phase 1, Phase 2 and Phase 3 clinical trials.