[Remote] Senior Project Manager - Autoimmune
Note: The job is a remote job and is open to candidates in USA. Precision Medicine Group is a company focused on delivering innovative solutions in the healthcare sector. They are seeking a Senior Project Manager to oversee clinical study projects, ensuring objectives related to quality, scope, cost, and time are met.ResponsibilitiesServe as primary point-of-contact and primary escalation point to the clientCoordinate and oversees all functional services including external vendors to the established timeline and budgetManage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as neededMaintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activitiesManage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectivesDevelop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and qualityEnsure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findingsMaintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentationEstablish tracking metrics to monitor trial and team progress towards project goalsPrepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they ariseLeads both internal and client meetings and set expectations for the project teamCommunicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issuesAbility to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defenses with proficiencyEnsure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the projectSupport business development and marketing activities as appropriate, including travel to Bid Defense meetings as requiredPerform other duties as assigned by managementRemain compliant with organizational training, time-reporting and any other administrative duties as requiredProvides on-going feedback, for functional team members including annual performance reviewsSkillsNorth America: Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferredEU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferredMinimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experienceExperience in managing complex and global trialsAbility to travel domestically and internationally including overnight staysExperience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMSProven communication and interpersonal skills to effectively interface with others in a team settingProven organizational skills, attention to detail, and a customer service demeanorDemonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such itemsDirect work experience in a global, cross-functional project management environmentGood understanding of cross-functional managementGood understanding of project planning, risk management and change management with an awareness of appropriate escalationProven experience in strategic planning, risk management and change managementHigh level of integrity and must inspire and demand the highest standards from a professional and ethical perspectiveAbility to lead and inspire excellence within a study teamAbility to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiencyResults oriented, accountable, motivated and flexibleProven time management, negotiation, critical thinking, decision making, analytical and interpersonal skillsProven presentation, verbal and written communications skillsGood understanding of project management softwareIn depth proven experience in pharmaceutical and/or device research requiredExperience with Rheumatology and OncologyBenefitsDiscretionary annual bonusHealth insuranceRetirement savings benefitsLife insuranceDisability benefitsParental leavePaid time off for sick leave and vacationCompany OverviewWe founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It was founded in 2012, and is headquartered in Bethesda, Maryland, USA, with a workforce of 1001-5000 employees. Its website is https://www.precisionmedicinegrp.com/pfm/.