The Senior Site Budget & Contracts Lead is responsible for providing the suite of Site Budget & Contracts Services to clients. They will participate on a project team to deliver Site Budget & Contracts Services on time, within budget, and in accordance with applicable financial, contractual, and pharmaceutical R&D industry standards and regulations. Their focus will be on the more complex projects (i.e. multiple countries, challenging therapeutic area).

Responsibilities & Essential Functions:

• Serve as the client’s primary point of contact for projects that are using a single Site Budget & Contracts service;
• Lead internal project kick-off meetings for single solution engagements which will include a review of the Statement of Work (SoW) and the service delivery model that will be followed to execute the services;
• Develop the investigator grant budget for the per patient grant and related site pass-through costs;
• Work with the (Sr) Site Budget & Contracts Manager to develop site-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), or other related contractual documents (collectively, the “contractual documents”) based upon client approved templates;
• Negotiate contractual documents using the negotiation and escalation plan that has been established with the client;
• Track the delivery of services against the SoW and ensure that agreed up project targets and/or milestones are being achieved;
• Lead client specific or departmental projects which may require oversight of other Site Budget & Contracts staff to ensure that these projects are delivered within the established timelines;
• Prepare ongoing unit based forecasts for assigned projects and measure performance against those forecasts;
• Serve as an internal escalation point for project related issues and challenges;
• Identify those elements that trigger an out-of-scope activity (i.e. additional tasks requested, timeline shift, sites added to the study) and work with the Associate Director, Site Budget & Contracts to prepare a Change Order;
• Serve as mentor to junior staff providing required training as well as addressing project questions/issues;
• Other duties as assigned

Qualifications:

• B.A./B.S. preferably in a business or science/health care discipline, nursing degree, or equivalent degree and/or related experience
• Proven prior experience in a client service role at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities;
• Prior experience leading staff, ideally in a clinical trials start-up group;
• Clinical study start-up experience with an emphasis on site contractual documents

Competencies:

• Analytical Thinking: Tackle problems by using a logical, systematic, sequential approach;
• Attention to Detail: Ensure that all work is complete and accurate with a focus on quality;
• Building Collaborative Relationships: Develop, maintain, and strengthen partnerships with others inside or outside the organization who can provide information, assistance, and support, including client and vendor relationships;
• Decisiveness: Make informed decisions in a timely manner;
• Technical Expertise: The ability to demonstrate depth of knowledge and skill in a technical area;
• Influencing Others: Gain others’ support for ideas, proposals, projects, and solutions;
• Initiative: Identifying what needs to be done and doing it before being asked or before the situation requires it;
• Time management: The ability to handle multiple tasks and changing priorities to meet deadlines in a dynamic environment;
• Oral Communication: The ability to express oneself clearly in conversations and interactions with others;
• Written Communication: The ability to express oneself clearly and succinctly in a professional manner;
• Coaching: The ability to coach junior staff, imparting knowledge and empowering them to succeed;
• Skill Requirements:
• Ability to motivate self and others when working under pressure to meet deadlines;
• Ability to think and act strategically;
• Proficient with Microsoft Office, specifically MS-Excel and MS-Word;
• Demonstrated ability to delegate effectively, co-ordinate a team to achieve results;
• Knowledge of the clinical trial process including GCP, ICH guidelines and relevant FDA/EC regulations/guidelines;
• Multi-language skills are a plus;
• Strong organizational, presentation, documentation, and interpersonal skills as well as a willingness to work in a team-oriented environment;
• Strong analytical and problem solving skills;
• Willingness to be flexible as the business requires

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com