strategic fp&a manager.

job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Cambridge, Massachusetts job type: Contract salary: $103.09 - 114.54 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s)Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet 's obligations described in ICH-GCP and 's business objectives.The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.Accountable for planning and operational strategy and execution for assigned clinical trials Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documentsChallenges study team to ensure operational feasibility, inclusive of patient and site burdenValidates budget and ensures impacts are adequately addressedParticipates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategyChallenges study team to ensure timelines meet the needs of the clinical development planEnsure new team members and vendors are appropriately onboarded During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in placeProvide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidlyResponsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROsOversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted;Specific areas of sponsor oversight include, but are not limited to: Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoringReview and endorsement of relevant study plans, as applicableStudy team meeting management and attendance when necessary; regular review of meeting agendas and minutesReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the studyDocumented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.Ensure studies are "inspection ready" at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections.Represent the Clinical Operations Manager role in functional initiatives or working groups.Help with onboarding and mentoring of new or junior COMs. May assist the program COPL in his/her role, as required.  qualifications: Bachelor's Degree or international equivalent required, Life Sciences preferred.6+ years' experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.Demonstrated excellence in project/program management and matrix leadershipExcellent communication skillsExcellent teamwork, organizational, interpersonal, and problem-solving skillsFluent business English (oral and written)  skills: GCP (Good Clinical Practice), ICH Regulations Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: Randstad Technologies is looking to add an experienced Project Manager to one of our top healthcare clients in the greater Boston area. Ideally, our client is looking for someone who is well versed with modern Microsoft Business Suites (M365) as well as being able to quickly obtain an understanding of existing projects and workstreams, technical capabilities, organizational capabilities, and business objectives to define the current state. This PM will be responible for fostering collaboration amongst the various stakeholders and technical teams, to identify future state goals and develop the business case and strategy to achieve the future state Modern Workplace.If you enjoy working in a highly collaborative department, please consider the following qualifications. If you have any questions about this position, please email Jesse Karassik at jesse.karassik@randstadusa.com directly.   location: Boston, Massachusetts job type: Contract salary: $55 - 75 per hour work hours: 8am to 4pm education: High School   responsibilities: Our client's strategy is to focus on the new 'Modern Workplace', putting user experience at the front and center of everything we do. This effort, will modernize and revolutionize the way our users currently work, offering them a more simplified set of tools on a more standardized platform, with an emphasis on a single cohesive experience across all device types. The priority is to accelerate our overall technology and digital strategy for the 'Modern Workplace', and to create a scalable program to foster and enable this rapid growth and cross-functional collaboration. One key component of the program is to fully realize our existing investment in the Microsoft 365 platform, reducing duplicative toolsets and redundancy in offerings, and looking for cost savings opportunities. Organizational changes will need to continue to be made to adapt our business to the evolving platform, to set us up for success in this ever scaling and changing environment. Simplification and standardization of the platform and our offerings is paramount to what drives the program, leading to a better overall user experience and improvement in administrative capabilities and response times. In this program, we will obtain an understanding of existing projects and workstreams, technical capabilities, organizational capabilities, and business objectives to define the current state. The Modern Workplace program will foster collaboration amongst the various stakeholders and technical teams, to identify future state goals and develop the business case and strategy to achieve the future state Modern Workplace. Scope The scope for this program will include the strategy and planning for the Modern Workplace, inclusive of all Microsoft 365 applications and services. The Modern Workplace program will perform the following activities: Project Setup Define a detailed project plan and identify key stakeholders for the programDevelop a list of interviews required to understand current state of all Microsoft 365 applications and servicesDefine and agree upon success criteria for the programConduct a kickoff with all the key stakeholders to socialize scope, activities, and deliverablesIdentify and collect available data and analysis conducted to date, including current project efforts, application rationalization, integration dependencies, current contractual obligations, operational structuring, and other available data Current State Analysis Evaluate current state across people, process, governance, and technologyReview existing application strategyAnalyze cloud and on-premises architecture designConduct interviews with the stakeholders to understand organization, responsibilities, business objectives, and dependencies. Target State Design and Roadmap Define our specific operating model and program strategy using best practicesDevelop decision framework for agile operational decisionsIdentify and recommend services for future state opportunities Look at the existing EA agreement with Microsoft to find further ability for cost savings and an enhanced application offering Collaborate with program stakeholders to prioritize focus areas and business driven initiativesEnsure alignment with Microsoft, staying in parity with their future state vision Implementation Facilitate execution of project roadmap and prioritized initiativesCollaborate with the various implementation teams to ensure proper sequencing of initiativesWork with implementation teams to track progress and gather key metrics for successProvide reporting structure and dashboard for tracking overall success of the program and across the various initiatives and workstreamsImplement feedback loop to ensure all key stakeholders and program participants are kept alignedEnsure alignment with Microsoft, utilizing any programs or engagements to expedite growth through our existing agreementProvide a consistent structure for change management across the various groupsDevelop project goals, objectives, approach, and scope through negotiation and diplomacy that result in a well-defined, well-sponsored project.Develop work plans and timelines to meet project goals.Contribute to the development of IT strategies and solutions that align with Information Systems standards and strategic directions.Contribute to the development of capital and operating funding requirements associated with a project. Manage a project within its budget.Work independently but recognize when the involvement of senior management is required.Plan, manage and oversee projects, using recognized project management methods including: Definition of project scope and objectivesManagement and status reporting toolsFeasibility and cost benefit studiesRequirements definition (functional and/or technical) System testing/quality assuranceTrainingImplementationPost-implementation/on-going support Project administrative activitiesDocumentation Manage projects within the context of the larger environment including competing priorities, staffing levels, and budgetary concerns. Provide appropriate and timely problem escalation (including potential solutions where applicable) to both Information Systems management, project steering committees, and executive management.Provide on-going project status reports to Information Systems management, user groups, project steering committee and executive hospital management.Establish and create a positive project environment through leadership and mentoring.Provide quality customer service, providing on-going communication, feedback and follow-through with customers and executive management.Use/s the the client values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration   qualifications: Experience level: ExperiencedMinimum 5 years of experienceEducation: High School  skills: Project ManagementModern WorkplaceOffice 365MS OfficeSharePointProject Management Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: The Senior Manager, Digital Engagements Analytics & Insights reports to Associate Director of Global Medical Operation, Analytics & Insights and serves as a key partner and leader for various strategic and operational excellence initiatives. This position provides overall Medical Affairs leadership and guidance for flawless execution and delivery of digital tools and processes to optimize and measure the value created by GMA, and advancement of an integrated Digital Medical Strategy (e.g., insights management, materials management, communications/awareness tools).   location: BOSTON, Massachusetts job type: Contract salary: $58.00 - 65.50 per hour work hours: 9am to 5pm education: Bachelors   responsibilities: Principal Responsibilities This position encompasses core GMA responsibilities that span across: Digital Enablement Scope and support effort to optimize insights management (initially across Medical Affairs functions) through structured targeting, collection, analysis, sharing and incorporation into TAs' strategy and/or tactical plans Development of integrated data and platforms to streamline user experience HCP Engagement and Medical Performance Support planning, design, and deployment of CRM, including advanced reporting, HCP engagement planning and insight gathering/analysis Contribute to building integrated platforms including: analytics, reporting, and integrated reporting tools/dashboards for key metrics to minimize manual burden and highlight value of field teams in medical Concept, building, and management of governance structures for multiple data analytics and platforms GMA support Deliver full suite of PMO tools that provide adequate operational details while not being too onerous for GMA internal colleagues to support and maintain Coordinate regular internal GMA meetings that are well planned, agenda driven, professionally facilitated, and tracked through formal notes and action items Customize launch, training, and communications for existing and upcoming tools, dashboards, and capabilities to medical and cross functional teams and leadership Qualifications 5+ years of experience within the biopharma/healthcare technology industryExperience/exposure in digital product development, with the ability to liaise with stakeholders and vendors to design and implement digital solutions with these strategiesAbility to design and deliver workshops that engage relevant cross-functional internal teamsDemonstrated ability to implement projects of strategic importance on time and on budgetExperience managing global projects with team members in multiple locationsSpecific experience with pharmaceutical, medical device, product, and/or indication launchesForesight and judgment in making complex decisions, independently when neededCritical analysis and problem solving skills, with the ability to apply these skills pragmaticallyAbility to maintain confidentiality with sensitive informationMeeting facilitation skills (personal organization, advanced preparation, and follow-up)strong command of the full Microsoft Office suite, particularly Excel and PowerPointUnderstanding of medical affairs organizations and their role within biopharma companies and the broader industry strongly preferredExperience with building and leveraging CRM, BI, and training applications (eg Veeva CRM, Qlik, WalkMe, MindTickle, Jira)Experience with agile methodology, Scrum Education BA/BSc or MA/MSc ,(business-oriented, data science, computer science)Graduate Degree (PhD) preferred, but not requiredProject Management Certifications a plus, but not required Competencies Has Global FocusStrategic ThinkerDecision QualityProblem SolvingAccountabilityPeer RelationshipsTime ManagementPerseveranceRoll up your sleeves attitude   qualifications: Experience level: ExperiencedMinimum 3 years of experienceEducation: Bachelors (required)  skills: Product ManagementveevaCRMBusiness AnalysisQlikPowerBIVeevaCRMVeevaVaultUATWalkMeSalesforceGMAGlobal Medical Affairs Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.