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Thermo Fisher Scientific

Product Manager

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionManages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.  Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.  Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.  Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits(AFVs) and be accountable for project financials.  Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.  May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.  Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.  In North America, where assigned to GPHS (Government &amp; Public Health Studies) projects, may have limited line management responsibilities.

Sr. CTM - FSP

Staff Specialist, Quality (Auditor)

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Sr. BioProduction Account Manager - Philadelphia

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSummarized Purpose: Ensures the delivery of safety management services consistent with company SOPs/WPDs, ICH guidelines and regulatory requirements. Works with managers and liaises with other departmental personnel as required. Oversees function operations and manages the activities of managers and other staff. Develops and maintains departmental SOPs/WPDs, and long-range planning for new processes and staffing needs.Develops business proposals and client presentations, and interacts frequently with members of the Business Development and Bids and Contracts groups. Essential Functions and Other Job Information: Essential Functions  Oversees effectiveness of department operations to include safety processes, resource utilization, scope of work, budget and contractual issues.  Develops processes and strategies designed to assist in meeting departmental and company goals.  Oversees compliance with all relevant company policies, procedures and global regulations.  Guides managers and trains project team members as appropriate.  Assists business development and fosters client relationships and provides department business development presentations for clients to help secure new business as well as retain ongoing business for existing clients.  Reviews and provides operational input on budgets, proposals, contracts and/or renewals associated with existing clients.  Manages staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Policy &amp; Strategy Establishes operating policies &amp; procedures that affect departments and subordinate sections of work units. Interprets company-wide policies and procedures. Develops budgets, schedules, and performance standards. Freedom to Act Assignments are objective oriented. Work is reviewed in terms of meeting the organization's objectives and timelines. Liaison Interacts frequently with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and / or contractual clarifications. Leads briefings and technical meetings for internal and external representatives.Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years). 5+ years of management responsibility Proven leadership skills In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:  Expertise in global regulatory requirements for adverse event reporting, ICH safety guidelines, GCP etc.  Knowledgeable of safety database management  Expertise in budgeting, forecasting and fiscal management  Analytical skill as well as excellence in oral and written communications  Ability to handle multiple issues on multiple projects simultaneously  Ability to maintain a high degree of independence with respect to decision making and problem solving  Ability to act as liaison with other divisions necessary to complete contract/regulatory requirements  Strong negotiating skills  Ability to analyze and evaluate processes and proceduresManagement Role: Directs through lower management levels and / or highly skilled specialist employees who exercise significant latitude and independent judgment. Often heads one or more departments or a large centralized staff function. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions. Working Conditions and Environment:  Work is performed in an office environment with exposure to electrical office equipment  Daily exposure to high pressure and intense concentration  Daily interactions with clients/associates  Long, varied hours on occasion  Travel required occasionally domestic and/or international Physical Requirements:  Frequently vertical and /or stationary for 6-8 hours per day.  Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.  Frequent mobility required.  Frequent bending and twisting of upper body and neck.  Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.  Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

38 Thermo Fisher Scientific Jobs