Contracts Analyst - Outsourcing

Delta Pharma is a leading National Clinical Research service and consulting firm. We are searching for quality Clinical Research professionals to join our team in helping our clients in the pharmaceutical industry navigate the clinical trials process. We offer a strong benefit plan and competitive compensation program.

Delta Pharma is a member of the Vedior Group of companies, the third largest international staffing firm with over 2,300 offices in more than 43 countries.



Responsibilities:

 ·         Manage the development, negotiation and execution of investigator/clinical research site Clinical Trial Agreements (CTAs) in support of the activities for Phase I-IV clinical studies worldwide, in accordance with all governmental regulations, guidance documents, and SOPs.  Studies will be managed directly by sponsor.

·         Work with Investigator Grants Manager and organization Legal to develop standard CTA template for company sponsored clinical trials

·         Work with organization Legal and Clinical Operations staff to develop a Master Services Agreement (MSA), incorporating all pertinent elements and reflective of the study protocol requirements, with investigators/clinical research sites/institutions who can accommodate such an agreement

·         Primary contact for investigators and clinical site personnel for contract issues

·         Work closely with organization to resolve complex contract issues

·         Review all individual site contracts to ensure that all necessary terms and elements are appropriately included before distributing for signatures

·         Identify contract issues related to scope of the clinical trial, amendments, resource allocations, budget/payment terms and budget design, etc. to reduce organization legal, financial, and quality risks and work with the appropriate staff in Clinical Operations and organization Legal to resolve issues.

·         Work with organization Investigator Grants Manager(s) and Clinical Operations to establish budget guidelines and payment terms/schedules for organization sponsored clinical trials

·         Coordinate efforts with Clinical and Site Operations to ensure contract development and negotiation are in concert with those activities in the site initiation phase for a given study

·         Ensure that a fully executed CTA is in place prior to subject enrollment at investigator site(s)

·         Anticipate and identify issues that could affect timelines and works with management staff to develop alternative solutions

·         Provide updates of contract management activities to management and or present at team meeting as requested

 

Miscellaneous

 

·         Provide input into the development of operational processes to support contract activities of organization sponsored clinical trials. 

·         Ensure implementation and maintenance of an efficient and consistent process for the preparation, negotiation and execution of CTAs.

·         Populate and keep all contract information current in the appropriate database. 

·         File original and completed CTAs in the appropriate document management files.
Assist Investigator Grants Manager with clinical study budget development, negotiation and execution as directed

·         Ensure self-proficiency on new processes, technologies and systems

·         Function as a resource for Clinical and Site Operations for routine contract-related questions

·         Works directly with Clinical Operations to confirm/finalize clinical site study budgets for non-outsourced organization sponsored Phase I-IV clinical research studies

·         Reviews individual site budgets to ensure all terms and elements are included before incorporation into the final contract

·         Enters study site information into Financial Management Software template for incorporation into final Clinical Trial Agreement

 

EDUCATION:

·        Bachelor’s degree and 3+ years in contract management required. 

·        Pharmaceutical or CRO experience preferred.

·        Demonstrated negotiation skills.

 

DESIRED EXPERIENCE:

 Experience in negotiation of contracts with clinical research sites.