Site Contracts Service Delivery Mgr.
REPORTS TO :
Director Level Site Contracts / Integrated Site Services (ISS)
BASIC FUNCTIONS :
Responsible for the oversight of service delivery for studies having Site Contracts services by supporting the Site Contracts team to ensure compliance of the Site Contracts process at IQVIA Biotech.
Provide strategic planning and oversight to support the staff, ensuring activities are in line with contracted scope; executed towards timelines set forth in the study;
monitor the resourcing requirements of assigned studies; review financial reports to track execution towards proposed budget;
and, support the efforts of Site Contracts team members, ensuring clear client and internal team communication. Develops study delivery plans and timelines and drives deliverables and tracks against those targets.
Oversees the site contracts team to ensure contract templates and individual site contracts are following International Congress on Harmonization-Good Clinical Practice (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients.
Provide mentorship to Site Contracts team members. Provide support to identify and mitigate risks that may arise during the study.
Support and coach the Site Contracts team through project level problem solving.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES :
Supports the Site Contracts team members in the start-up phase, serving as a point of escalation for Project Team members, if needed.
Develops a study timeline for the overall progression of the study from the time of award until the conclusion of final contract negotiations.
Develops a study delivery plan as it relates to timelines for template development and execution of site contracts with sites.
Communicates the study timeline and delivery plan to the template development and site contracting staff to ensure they understand their targets.
Tracks and reports progress against the study timeline and study delivery plan to ensure targets are being met.
Meet regularly with Site Contracts Management team to provide progress updates.
Supports Template Development Team with preparing a template development delivery plan and timelines, working with the Study Start-up Manager and Project Manager as necessary to confirm overall study timelines are maintained.
Oversees key accounts and portfolios by assuming Site Contracts service study oversight responsibilities and helping to develop strategies to support the team to deliver execution of study timelines, corporate and department quality metrics, resource management, performance oversight, and team collaboration activities.
Communicates challenges and concerns to Site Contracts and SSU Line and Department Management, as well as Project Management where necessary.
Liaises with Line Managers regarding resourcing challenges, performance issues observed or training requirements.
Mentors employees as needed in the implementation of their tasks, timelines, navigating study challenges and responsibilities within their job description.
Provides support where needed on sponsor communications to ensure a clear message is given and supporting where necessary on dealing with challenging sponsors.
Attending meetings where necessary.
Ensures assigned Template Developers and Site Contracts Associates are providing clear and accurate communication to other departments and where necessary challenging the data provided.
Conduct regular Quality Control checks of study contracting documents, study status trackers, dashboard reports, compliance with department SOP’s and adherence to study specific processes.
Participates in financial oversight and ensures financial deep dives are completed on studies and out of scope activities are alerted to Management, PM and study team to ensure that such activities do not begin until authorization by PM and Management has been provided.
Provide support where necessary to ensure Site Contracting team members understand budgets for the studies they are working on and they maintain accountability for notifying Project Managers when additional activities may cause budget overburn.
Ensures the Site Contracts teams are prepared for upcoming audits by evaluating quality metrics and liaising with the study lead on any outstanding items.
Identifies areas of process improvements and coordinates with Site Contracts global management team to resolve issues;
includes supporting process development, strategizing study management improvements and updates to trainings and / or SOP / WP.
Collaborates with line management when staff performance issues are identified on a study and provides support to line management to resolve any staff level issues.
Performs other duties as required to ensure study compliance, completeness and staff support.
KNOWLEDGE, SKILLS & ABILITIES :
Demonstrated ability in the leadership of a team of individuals in Site Contracts process
Extensive knowledge of the global clinical research site contracting process and legal terminology
Can clearly communicate the site contracting plans to others and can quickly and concisely direct others to issue resolutions
Exhibits strategic thinking skills to support timely completion of deliverables
Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
Excellent planning, organizational and interpersonal skills
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
Perform tasks with special attention to detail to ensure the highest quality work product
Excellent contract and budget negotiating skills
Excellent listening skills
Understands the global site contracting process clearly
Ability to manage multiple competing priorities within various clinical trials and across clients
Ability to gain successful outcomes in areas of challenge regarding Site Contracts process / implementation
Strong understanding of project financials & applicable tools
Ability to provide mentorship and oversight of all Site Contracts processes
MINIMUM RECRUITMENT STANDARDS :
3-5 years of prior relevant site contract and budget negotiation experience
BS / BA / BSc or equivalent level of education, training and experience
Excellent verbal and written communication skills required
Ability to work independently, prioritize and work with a matrix team environment is essential
Working knowledge of study budgets and forecasting resources for projects
Understanding of how to evaluate resourcing needs for projects
Working knowledge of Word, Excel is required
Extensive knowledge of current ICH GCP guidelines and applicable regulations
JOB FUNCTIONS :
Ability to travel, when required
Very limited physical effort required to perform normal job duties
At IQVIA, 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.
The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our ,+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.