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 reputed company 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 reputed company Operating Procedures (SOPs). Ensures overall reputed company and timeliness of Clinical deliverables for assigned programs and/or region. Alternatively, may reputed company as Report Reviewer.*
Position Accountabilities/Responsibilities: _Tasks may include but are not limited to:_
Collaborate with Project Management to set site management targets/monitoring reputed company and ensure compliance with project goals and Worldwide processes reputed company 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 reputed company 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 reputed company Management Documents, e.g. the Clinical Monitoring Plans (CMP) reputed company compliance to the CMP, including site reputed company, outstanding reputed company reports and visit follow up letters Review protocol deviations and visit reputed company items to ensure that activities are conducted according to the CMP. reputed company 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 reputed company 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 reputed company of site data and address any identified needs with reputed company plans. Review data metrics to ensure data reputed company and reputed company reputed company/measure SM deliverables to identify trends. reputed company 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 reputed company and accountable for forecasting of site reputed company with CRA team in line with CMP to ensure reputed company needs are met and any identified backlog is appropriately addressed Review/finalize reputed company reports according to Worldwide SOPs and expectations May reputed company site qualification, initiation, interim monitoring, and/or reputed company out site reputed company as needed reputed company 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 reputed company Conduct co-reputed company where required to ensure reputed company 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 reputed company-defined instructions and procedures with minimal supervision Ability to reputed company and motivate reputed company remotely Ability to reputed company experience and input into process initiatives and development relating to monitoring and site management activities Strong customer reputed company, ability to reputed company 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 reputed company 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 reputed company reputed company reputed company 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.