1) the below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties. 2) responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned 3) responsible for all aspects of site management as prescribed in the project plans 4) general on-site monitoring responsibilities 5) ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study 6) ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements 7) ensure the integrity of the data submitted on case report forms (crfs) or other data collection tools by careful source document review 8) monitor data for missing or implausible data 9) ensure the resources of the sponsor and covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to sops and established guidelines, including managing travel expenses in an economical fashion according to covance travel policy 10) ensure audit readiness at the site level 11) travel, including air travel, may be required and is an essential function of the job. 12) prepare accurate and timely trip reports 13) responsible for all aspects of registry management as prescribed in the project...
Develop and review contracts for low to medium complexity projects and see through to execution (including cdas, isas, ipas, wscs, budgets if required, etc; excludes msas) - generate cash flow analysis and payment schedules with high degree of management support for the above mentioned agreements in accordance with contract management guidelines for review by senior members of the department - follow up on outstanding contract issues for resolution to meet internal and external deadlines and to minimize business and legal risk - work cross-functionally with contract analysts, client services, finance, pricing and sales to resolve contract issues in a timely manner - assist analysts and smes with periodic client f/up for contract documentation - assist in managing overall contract processes and client relationships - participate in process improvement initiatives intended to improve global delivery of contracts - adhere to contract management policies and process - ensure sarbanes oxley compliance from a contracting perspective - perform accurate data entry into sfdc, apttus, cms and/or other tools required for reporting - provide accurate updates on all outstanding contractual documents to management as required through required systems or tracking mechanisms - participate in project review meetings as necessary - other duties as assigned **labcorp is proud to be an equal opportunity employer**: as an eoe/aa employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexu...
**essential job duties**: *** - lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines. - as the lead data manager, be accountable for all dm deliverables as assigned per the established timeline; providing instruction to their dm study team(s) and review of their study team’s output to ensure the highest quality, while adjusting resource allocations accordingly. - ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized sops, and the specified standards of gcps. - work with the project manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings. - provide dm project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of edc design, sas programming, statistics, and pk to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the project manager or designee apprised of project progress. - maintain awareness of other biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on dm resources or deliverables and consult with project manager or designee ...
**labcorp is proud to be an equal opportunity employer**: as an eoe/aa employer, labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. we make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. we encourage all to apply. for more information about how we collect and store your personal data, please see our privacy statement....
The associate start-up project manager oversees and manages the start-up phase of domestic and/or international clinical trials, primarily on a regional level but can hold a lead role depending upon supm experience level. responsibilities include project managing defined study start-up activities within timelines, scope, quality and budget, ensuring that client’s expectations are met. job duties include overseeing the maintenance phase, as applicable. essential job duties: depending on the scope of the project and experience level, job duties below may be performed independently as a lead supm or in collaboration with a lead supm as a regional supm. lead supm is accountable for all job duties below. regional supm supports lead supm by leading below job duties on a regional level. general lead start-up team during study start-up phase liaising directly with lead supm or project lead, core team members and the client, as applicable.. serve as client’s contact for start-up and maintenance processes and oversight. responsible for establishing a strong working relationship with client’s project teams. monitor and control start up project schedule, budget, and scope. proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. initiate improvements to enhance the efficiency and the quality of the start-up work performed on assigned projects. finance management ensure that work is performed within budget. interpret billing guidelines for the functional area/region and schedule training for start-up team a...
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