Manages the preparation, negotiation and finalization of"Investigator Contracts" templates, process and negotiation parameters(including, contractual terms and conditions, and ancillary documents), and oversight of associated investigator grant budget(s), associate payment schedule terms and conditions with an assigned workload of clients. Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with PPD contractual considerations, client contractual considerations, established process with clients and follows established escalation routes. Liaises and establishes effective relationships with clients and internal PPD functional teams, as directed by Associate Directors/Directors. Ensures quality, objectivity and risk analysis in the efficient delivery of Investigator Contract templates, process and negotiation parameters. Drafts, reviews, negotiates and finalizes "Investigator Contracts"templates, process and negotiation parameters with clients in accordance with PPD contractual considerations and processes
- Communicates, trains and provides approved "Investigator Contracts" templates, process and negotiation parameters and client expectations to assigned Contract Specialist teams
- Ensures collaboration, quality alignment with terms and conditions, process and client expectations with assigned Investigator Grant Analyst(s).
- Identifies and assesses legal, financial and operational risks in accordance with approved PPD and client contractual considerations.
- Acts as a Lead regional interface and escalation contact with external clients for "Investigator Contract" term & condition revisions outside of approved negotiation parameters, client expectations and process deviations.
- Provides recommendations and alternative resolutions to Investigator Contracts negotiations to internal and external clients.
- Works with internal functional departments to facilitate coordination of different site start-up activities impacted by contractual activities upon mutually agreed upon timelines
- Completes tracking and reporting as required
- Contributes to change initiatives within the SIA department
- Completes periodic quality reviews and peer feedback reports
- May assist with training material preparation or delivery of training to Contract Specialist or Investigator Grant Analyst teams.
Minimum Required Education and Experience:Bachelor's degree0 - 5 years of related experience in area of supervision and1 year of leadership responsibilityRequired Knowledge, Skills and Abilities:Demonstrated understanding of regional principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp lawsDemonstrated ability to apply basic principles of investigator grant negotiationGeneral understanding of business, contractual and financial principles that related to service agreementsEffective communication skills (verbal and written) in English and in language spoken at your local place of work.Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parametersStrong attention to detailExcellent analytical and decision based thinkingDemonstrates depth of knowledge/experience of clinical drug development and trial process, attained within the pharmaceutical and/or CRO industryAble to work independently or in a team environmentExcellent organizational and time management skillsWorking knowledge of PPD SOP and WPDsAble to organize competing priorities logically and review outstanding contractual risk and issuesAbility to demonstrate a customer focused style of communication,problem solving and collaborationAble to effectively use automated systems and computerized applications,such as, Microsoft Outlook, Excel, Word, etc.Flexible and able to multi-task and prioritize competing demands/work loadPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.