Hi,
Pleasure mailing you. Please go through the below requirement and let me know if you are comfortable for the position.
Please send me your updated resume along with the best hourly rate, work authorization status and availability.
An early response is really appreciated.
Job title : Site Contracts Manager (SCM)
Location : California (Day 1 onsite)
Duration : 12 Months
Job Description:
• Support the Head of Site Contract Management in the outsourcing and contracting of clinical trial studies (main responsibility).
• Managing and maintain Investigator related Sharepoint, assisting in the generation of the clinical trial budget development, assisting and handling the formatting, signatures and communication with global sites entering into Master Clinical Trial Agreements (MCTAs).
• Support our clinical development teams (Phase I-IV) in the outsourcing and contracting clinical sites. (as possible).
• Ensure best terms and conditions with the contracted clinical sites in all clinical trials.
• Point of contact for the MCTAs with sites.
• Ensure that study timelines are met by collaboratively working with the clinical study team to manage CROs selected for the clinical studies. (as possible with Budget generation).
MAJOR ACCOUNTABILITIES
• Support the Head of Site Contract Management in the outsourcing and contracting of clinical trial studies (main responsibility).
• Managing and maintain Investigator related Sharepoint, assisting in the generation of the clinical trial budget development, assisting and handling the formatting, signatures and communication with global sites entering into Master Clinical Trial Agreements (MCTAs).
• Lead negotiation of documents for clinical sites including, but not limited to clinical site agreements and budgets, indemnification letters, power of attorney, confidential disclosure agreements.
• For each new trial, assist in detailed specifications with regards to budget (acceptable frame of fees) in collaboration with the clinical project team, customize needed investigator contracts templates and develop associated specifications for the contract negotiation) in collaboration with Legal.
• Distribute the developed specifications to the selected CRO and instruct the CRO about the negotiation strategy with the clinical sites.
• Support negotiations and management of investigator contracts (including fees/budgets) to insure a cost-effective, expeditious and successful solution to our needs.
• Take the lead on negotiations where necessary. Same responsibilities with scope changes.
• Ensure that all investigator contracts appropriately represent the responsibilities of the various parties involved in the clinical study.
• Track and ensure execution of all site and investigator contracts, distribution and proper documentation.
• Insure that all UCB SOPs are adhered to and federal regulations and GCP guidelines are followed with respect to OC&SP.
• Ensure that vendor and investigator performance is regularly assessed and shared with relevant interfaces during regular debriefings.
• Participate in clinical team members training on the site agreement process.
Education
• Describe the minimum level of education necessary for this role: Bachelor's Degree
• Experience
• List the type and length of experience
• Budget/excel and pharmaceutical/CRO
COMPETENCIES
• Significant experience with clinical trial budgets generation, tracking, communication skills with investigational sites in North and South America, Europe and the Rest of the World.
• Experience in the Pharmaceutical, Biotechnology, or CRO industry, a must (minimum number of years 5-8 years).
• Good leadership skills, networking skills, and communication skills.
• Demonstrates clear and articulate verbal, written and presentation skills (power point) with good command of the English language and MS Word redlining, and formatting skills.
Thanks,
Maneendra K
US IT Recruiter
Email : maneendrak@tekskillsinc.com | www.tekskills.in
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