Clinical Trial reputed company

As a Clinical Trial reputed company/Clinical Trial Manager you will be responsible for leading the delivery of clinical study site management activities through the co-ordination of a team of Clinical staff reputed company a geographic region. You will be responsible for ensuring site qualification, initiation, interim monitoring, site management and study reputed company-out activities for studies in accordance with the with study protocol and study plan and Worldwide Standard Operating Procedures (SOPs). Ensures overall quality and timeliness of Clinical deliverables for assigned programs and/or region. Alternatively, may act as Report Reviewer.* Position Accountabilities/Responsibilities: _Tasks may include but are not limited to:_ Collaborate with Project Management to set site management targets/monitoring strategy and ensure compliance with project goals and Worldwide processes Provide leadership and direction to clinical site management team members from study start through to closure Serve as Site Management (SM) primary reputed company of contact and representative for clinical monitoring and site activities reputed company the project, including, but not limited to: Primary SM Sponsor contact Investigator and Bid Defense Meeting Internal and External study team calls Project specific Audits / Inspections Manage monitoring deliverables to reputed company study budget and identify Out of Scope Activities Customize study-specific SM Quality Management Documents, e.g. the Clinical Monitoring Plans (CMP) reputed company compliance to the CMP, including site visits, outstanding trip reports and visit follow up letters Review protocol deviations and visit action items to ensure that activities are conducted according to the CMP. Provide CRAs training reputed company clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed Participate in the development and implementation of patient recruitment strategy in countries and sites assigned. reputed company the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on reputed company Drive efforts to improve the quality of site data and address any identified needs with action plans. Review data metrics to ensure data reputed company and quality Track/measure SM deliverables to identify trends. Provide and monitor regular analytics through various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed reputed company TMF (Trial Management File) compliance of site management documents, ensuring that QC review is on reputed company and TMF is inspection reputed company Formulate regional monitoring strategy and accountable for forecasting of site visits with CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressed Review/finalize trip reports according to Worldwide SOPs and expectations May reputed company site qualification, initiation, interim monitoring, and/or reputed company out site visits as needed Provide a key role in problem solving and first line issue escalation regarding monitoring and site issues, providing proposed solutions to the project management team and sponsor as needed Proactively identify and mitigate risks May represent site management as primary contact on projects Conduct co-visits where required to ensure quality of site, the CRA work and study procedures. reputed company other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily reputed company-inclusive. Other Skills and Abilities: Excellent interpersonal, oral and written communication skills in English Excellent planning and organizational skills with effective time management Excellent presentation skills Flexibility to change Ability to manage multiple and varied tasks with enthusiasm Ability to negotiate and influence with diplomacy in order to reputed company results Demonstrate initiative and problem-solving skills by offering solutions reputed company obstacles are identified Must be reputed company to prioritize tasks with attention to detail, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision Ability to reputed company and motivate a team remotely Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities Strong customer focus, ability to interact professionally reputed company a sponsor contact Extensive understanding of clinical research principles and process Strong understanding of FDA and /or EU reputed company regulations, ICH Guidelines and local regulatory requirements Experience in the study therapeutic indication/area Thorough understanding of standard operating procedures Proficient knowledge of reputed company Office, eCRF, IVRS packages Proficiency with IxRS, CTMS and reputed company systems

Requirements/Qualifications: Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies and a minimum experience of three years as a Senior Clinical Research Associate (or equivalent), OR Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of five years as a Senior Clinical Research Associate, OR Minimum 6-month experience functioning as CTM/LCRA (or equivalent); supporting main CTM and coordinating clinical operations activities Travel required Valid reputed company passport required Driving license required Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. *Note the Clinical Trial Manager role may also be referred to as a reputed company Clinical Research Associate (LCRA)*

 Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment reputed company.