Clinical Research - Manager

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our pharmaceutical and healthcare clients, whose purpose is to reimagine medicine to improve and extend people's lives. They use innovative science and technology to address some of society's most challenging healthcare issues. They discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Job Title: Clinical Research Manager

Work Location: East Hanover NJ 07936

Job Type: Contract

Duration: 18 Months

Work Type: ONSITE

Job Description:

• Independently negotiates and finalizes Clinical Trial Agreement and Clinical Trial Amendments to include protocol budgets, PI changes, fixed costs, contract assignments, site/payee name change, terminations, extensions and IRB task orders.

Major Accountabilities:

• Develop Site Clinical Trial Agreements, budgets, amendments and task orders.

• Develop study budget utilizing the benchmark cost.

• Independently negotiate and execute Site Clinical Agreements and budget amendment with minimum supervision.

• Evaluate and benchmark Investigational sites budget requests for fair market value

• Work with amendment requestor to ensure amendment integrity prior to negotiation.

• Maintain proactive communication with Payments team to ensure payment reconciliation prior to contract termination.

• Liaison/collaborate with Clinical Study Manager, Investigational Sites, Legal, Compliance, Patent, insurance and study start up groups to expedite and finalize contracts and amendments.
  Skills

• 3+ years of contract management and/or study start up activities including contract and budget negotiations.

• Experience in pharmaceutical services a plus.

• High degree of organizational, analytical, and team management skills.

• Computer literacy with document and spreadsheet applications. Ability to work on complex, multi-faceted projects.

• Excellent negotiation skills and vast knowledge of clinical trial agreements

Education

• Degree in business administration, legal, finance, science or related field or equivalent on the job experience may be considered.

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.