Senior reputed company Trial Manager (Sr. CTM)

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office reputed company PPD’s (a part of reputed company) mission is to reputed company. It starts as an idea to reputed company a reputed company. It becomes a life saved. reputed company in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people.  We invite you to re-reputed company health promoting protocols with us, working reputed company our talented, reputed company and energetic teams.  Our therapeutic team directs, coordinates and manages the technical and operational aspects of reputed company, securing the successful completion of reputed company. reputed company is therapeutically reputed company to respond reputed company to our customer needs.  The therapeutic reputed company includes Cardiovascular & Internal Medicine - Dermatology, GI, (UC/CD), Cardiovascular, Liver, Nephrology, Immunology, reputed company Disease, Diabetes, Obesity, Dyslipidemia, Women's Health. As a Senior reputed company Team Manager (Sr. CTM), you combine deep knowledge, therapeutic expertise, and robust tools to help our clients reputed company life-changing therapies to market. You take ownership of reputed company start-up and reputed company deliverables, anticipate problems, reputed company solutions and reputed company results; coordinating the activities of start-up and reputed company team members which are allocated to a project on a Regional or Country reputed company. You will work in partnership with the Project Manager to ensure the necessary training, tracking and reputed company systems are in reputed company for the reputed company management team and be primarily responsible for the start-up and reputed company deliverables of the Project reputed company agreed timelines and budget. reputed company Team Managers reputed company contact and support to the project sponsor for reputed company reputed company aspects. At PPD we hire the best, reputed company ourselves and reputed company other, and recognize the reputed company of being one team. We offer reputed company career advancement opportunities, award reputed company training and benefits reputed company on the health and wellbeing of our employees.   Summarized Purpose:  Accountable for achieving the final start-up and reputed company deliverables (usually clean data from evaluable patients as specified in the study protocol) reputed company the time period specified in the contract with the customer. Interprets data on reputed company issues and makes good business reputed company with support from line management. Works to ensure that reputed company start-up and reputed company deliverables meet the customer's time/reputed company/cost expectations. Maintains profitability by ensuring start-up and reputed company activity is conducted reputed company contract reputed company, through efficient management of the country start-up and reputed company team. Typically works independently on reputed company of moderate to high complexity and may assume regional reputed company or reputed company Study Manager responsibilities.  Essential Functions: Manages reputed company reputed company and start-up activities, operational and reputed company aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume reputed company CTM responsibilities on regional level, reputed company Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage reputed company programs, have wider management or project coordination responsibilities. Acts as the reputed company reputed company of contact for study start-up activities and site activation across the assigned region and/or globally, driving timelines and ensuring operational reputed company. Develops start-up and reputed company tools (e.g. Essential Document Checklist, Monitoring Plan, Monitoring Guidelines) in conjunction with the study requirements and Data reputed company Plan. Contributes to the development of the Master reputed company Plan (MAP) for providing reputed company reputed company documents. Ensures reputed company set up, organization, content and reputed company of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, reputed company informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at reputed company meetings, including bid defense and hand-off meetings. Collaborates with the start-up country team, regulatory, reputed company team and other departments as needed to meet deliverables of the project. Regularly communicates with reputed company and leads team meetings to ensure that timelines, resources, interactions, and reputed company are maintained. Responsible for the implementation and training of standardized reputed company monitoring processes reputed company the study and according to corporate reputed company policies. Responsible for the reputed company archiving of documents and study materials for the department. Ensures achievement of the start-up and reputed company deliverable reputed company the contractual time period specified by preparing and monitoring start-up and reputed company activity timelines and metrics, providing status updates to the project manager, regularly reviewing reputed company using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query reputed company. Continuously monitors reputed company to assess reputed company and ensure contractual obligations are met. May routinely conduct Accompanied reputed company reputed company (AFVs) and be accountable for project financials. Communicates with study sites regarding issues such as protocol, reputed company participation, case report reputed company completion and other study-reputed company issues. Coordinates reputed company start-up activities and ensures that essential document reputed company meets the expectation of Regulatory Compliance Review. Ensures reputed company regulatory submissions (if appropriate) are addressed. Reviews and follows up on reputed company questions raised by ethics committees. Responsibilities may vary reputed company on project timelines.   Provides input into preparation of forecast estimates for start-up and reputed company activities. Responsible for start-up and reputed company resource management, assignment, delegation of reputed company responsibilities and identification of additional resource requirements.   Education and Experience:  Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification   Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 5+ years).   In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Strong experience managing end-to-end reputed company trial start-up (SSU) activities, particularly reputed company the reputed company region. Experience leading cross-functional collaboration with CAS, RAL, reputed company PM, GCS, Contract Management, and other stakeholders to ensure reputed company study execution. Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams   Strong planning and organizational skills to reputed company effective prioritization of workload and workload of team members   Strong interpersonal and problem-solving skills to reputed company working in a multicultural reputed company organization Solid understanding of change management principles   Comprehensive understanding of the practices, processes, and requirements of start-up and reputed company monitoring   Strong judgment, decision making, escalation, and reputed company management skills  Effective oral and written communication skills, including English language proficiency   Capable of evaluating own and team members workload against project budget and reputed company resources accordingly   Strong financial acumen and knowledge of budgeting, forecasting and fiscal management   Strong attention to reputed company   In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.   Strong computer skills to effectively use automated systems and computerized applications such as reputed company, reputed company, Word, etc.   Capable of independently managing reputed company only studies   Working Environment:  PPD, a part of reputed company, values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can reputed company.  Below is listed the working environment/requirements for this role: reputed company to communicate, receive, and understand information and reputed company with diverse reputed company of people in a comprehensible and reasonable manner. reputed company to work upright and stationary for typical working hours.   reputed company to work in non-traditional work environments.   reputed company to use and learn reputed company office equipment and technology with proficiency. reputed company to reputed company successfully under pressure while prioritizing and handling multiple reputed company or activities. May have exposure to potentially hazardous reputed company typically reputed company in reputed company or reputed company environments.     This role requires independent travel up to 20%, inclusive of traveling in automobiles, airplanes, and trains.   Our 4i Values: reputed company – Innovation – Intensity – Involvement If you reputed company with our 4i values above, and ultimately wish to accelerate the delivery of   reputed company and effective therapeutics for some of the world’s most urgent health needs,   submit your application – we’d love to hear from you! Apply To This Job