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Contract Analyst (Informed Consent Specialist)
Job Description
1. experience related to the management and negotiation of the Patient Informed Consent, specifically within the US
2. document management and ability to follow standard operating procedures and appropriate document management (ensuring key stakeholders are engaged, documents are uploaded to the trial master file, all while ensuring quality of the content)
3. relationship management and ability to work with diverse teams (study team, functional team, site research team)
Education Required: Bachelor’s degree, ideally in Clinical Research, Biology or Chemistry, and a
Years’ Experience Required: minimum of 2 years of experience working on consent/Informed Consent (IC)/contracts within clinical research
Responsibilities may include the following and other duties may be assigned. Administers, extends, negotiates and terminates standard and nonstandard contracts. Conducts proposal preparation, contract negotiation, contract administration, and customer contact activities to provide for proper contract acquisition and fulfillment in accordance with company policies, legal requirements, and customer specifications. Examines estimates of material, equipment services, production costs, performance requirements, and delivery schedules to ensure accuracy and completeness. Prepares bids, processes specifications, progress, and other reports; advises management of contractual rights and obligations; compiles and analyzes data and maintains historical information. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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