Study Management. Project Leader Project Administrative Support/Coordination
Study Management. The overall management of the study will be the responsibility of the Senior Clinical Trial Manager (CTM). The Senior CTM will oversee and coordinate the management of the study as well as oversee the study specific CTM. This oversight will ensure consistency and allow VIVUS Study Management to have one primary contact for the Qnexa program. The Medpace CTM assigned to OB-302 will work closely with the VIVUS Study Manager, Medpace Medical Expert, and VIVUS Clinical Leader to address protocol questions and interpretations while maintaining close oversight of study-related processes and documents. The OB-302 CTM will supervise all Clinical Research Associates (CRAs) and Project Coordinators assigned to the project. The Project Coordinators will be responsible for day-to-day study management functions, including the generation of status reports, organization of supplies, generation and compilation of newsletters, and input of all study information into the ClinTrak® Study Management System, a web-based, proprietary research management system designed by Medpace. The Project Coordinators will organize teleconferences and team meetings, including the compilation of agendas and meeting minutes. The Study Start-Up Manager and Study Start-Up Coordinators will work closely with the CTM and Project Coordinators to ensure sites become active in the most time effective manner. The Medpace Contracts Attorney will be responsible for the execution of Investigator contracts (upon VIVUS defined process). The Contracts Attorney will work closely with the Start-Up Manager and Medpace CTM to ensure contracts are executed in a timely manner. The Medpace Medical Expert assigned to this project will work closely with the VIVUS Clinical Leader. The Medpace Medical Expert will assist with protocol design and medical interpretation of entry criteria and adverse events (AEs). The Medical Expert will also be involved in the training of CRAs and other staff members participating in the project. The Medical Expert will review and approve the coding of concomitant medications, medical histories, AEs, and will provide the medical context for the statistical analysis and medical writing. The Medical Expert will assist in the review of the protocol, train Medpace personnel internally as to the background of the study compound and design of the study, participate in the project teleconferences and meetings, work hand-in-hand with the OB-302 CTM, and have heavy involvement in the clinical st...
Study Management a. Arapahoe County Representative. Arapahoe County hereby designates Xxxxx X. Xxxxxx as Arapahoe County’s representative to coordinate all communication with Columbine Valley related to the Study, including issues arising under this Agreement.
x. Xxxxxxxxx Representative. The City of Littleton hereby designates Xxxxxx Xxxxx as Xxxxxxxxx’x representative to coordinate all communication with Columbine Valley related to the Study, including issues arising under this Agreement.
c. Columbine Valley Representative. Columbine Valley hereby designates Xxxxxx X. Xxxxxx as Columbine Valley’s representative to coordinate all communication with the Parties related to the Study, including issues arising under this Agreement.
Study Management. 3.1.1 The study will be managed by a steering group comprising of staff from Nestrans, Aberdeen City Council, and Aberdeenshire Council. Nominated officers for the posts of Project Director and Project Manager are set out below. Any change of nominated officers will be notified in writing to the Consultant.
3.1.2 The Project Director for this study will be responsible for the strategic direction of the Project and Employer policy input. They will also be responsible for approving all deliverables and will have overall responsibility for project cost control and programme. The post holder is required to authorise all recommended variations to the study, brief, budget and programme.
3.1.3 The Project Director for this study will be Xxxxxx Xxxxxx, Team Leader – Transportation Strategy and Programmes, Aberdeen City Council.
3.1.4 The Project Manager is the co-ordinator and day-to-day manager of the project and point of contact for all project enquiries and submissions. The postholder will be required to consider and make recommendations on all applications from the Employer and the Consultant for variations to the study, brief, budget and programme.
3.1.5 The Project Manager for this Scheme will be Xxxx Xxxxxx, Senior Engineer, Aberdeen City Council with support from Xxx Xxxxxxx (Nestrans). Project Manager contact details are as follows: Xxxx Xxxxxx Transport Strategy & Programmes Planning and Sustainable Development Communities, Housing and Infrastructure Aberdeen City Council Business Hub 4 Ground Floor North Marischal College Broad Street Aberdeen AB10 1AB E-mail: XXxxxxx@Xxxxxxxxxxxx.xxx.xx
3.1.6 The project client group (as set out in 2.2.1) may be consulted at critical stages in the study programme and will give approval for work to be undertaken during the course of the study. Representatives from other agencies or Scottish Government departments may be invited to join the client group to comment on study proposals.
3.1.7 An update on progress should be provided to the client Project Manager on a monthly basis and include a report on expenditure (actual v. forecast), programme update (actual v. forecast) and reporting of any key issues.
Study Management. 1. The Quest Project Leader for any Study will interact on a regular basis with the GSK Clinical Study Leader or other designated GSK contact who shall be specified in each Task Description. Quest shall use its reasonable best efforts to retain such administrator's services for the length of each Study to which they have been assigned, in order to maintain the quality and consistency of Services. In addition, Quest shall provide a qualified back-up to such Project Leader. If such administrator's responsibilities change during the course of a Task Description, Quest shall notify the designated GSK contact of such change. Quest shall ensure that the level, quality and continuity of Services are maintained at the levels required by this Agreement despite any changes in personnel at Quest. The regional Quest Medical and Regulatory Affairs representative (or his or her designee) will use reasonable best efforts to review all concept or draft protocols at least 12 weeks prior to start of the Study (where made available by GSK) and comment on clinical testing, methodologies, sample collection/handling and sample stability. Where requested by GSK, Quest Scientific Affairs will obtain the input of Quest Diagnostics Academic Associates, Nichols Institute Scientists/Medical Directors and Nichols Xxxxitute Diagnostics personnel and use reasonabxx xxxx efforts to provide any appropriate recommendations for improvements to the GSK Clinical Study Leader within 10 working days.
2. Quest will provide to GSK and Investigators a toll-free telephone number for answering questions related to the Services. Quest shall also provide to GSK and Investigators the names and telephone numbers of Quest contacts who can answer testing related questions and take orders for supplies.
3. For Studies in the European Territory, Quest will provide sufficient personnel to communicate with Investigators and GSK personnel in English, French, Spanish, Italian, German and Dutch, as need be depending on the language requirements of the country in which the particular Study is performed. For Studies in both the North American and European Territories, Quest will provide GSK with access to a staff pathologist or an appropriately qualified Ph.D.- or M.D.-level staff member.
4. Quest technical support will be provided to interact with GSK and any GSK designated GSK agent or subcontractor for problem resolution. Quest will use its reasonable best efforts to resolve any technical errors promptly upon id...
Study Management. The client comprises the following organisations: • Cheshire & Warrington Local Enterprise Partnership • Cheshire East Council • Cheshire West & Xxxxxxx Council • Department for Transport Day-to-day management of the study will be carried out by a client group comprising officers of the these organisations. The Client Senior Responsible Officer is Xxxxxx Xxx, Chief Executive of the C&W LEP, and the Client Project Manager is Xxx Xxxxxx, Transport and Investment Director of the C&W LEP A working group will be established comprising officer representatives from the client organisations plus DfT, Network Rail, TfGM and Merseytravel, relevant Train Operating Companies. It is envisaged that this would meet regularly during the study. Although a considerable amount of the work is technical, we want to make sure that it is rooted in, and properly reflects, the views and aspirations of users of the railway, as well as other stakeholders, hence a wider stakeholder reference group has also been established. It is envisaged that this group will be convened three times over the course of the study: at the beginning (around mid-May) for consultants to introduce themselves to the group and identify any key issues/priorities, once during the study for any local knowledge/comment/input process, and towards the end of the study to consider the emerging conclusions. It is anticipated that the consultant would provide regular updates to the Client Group, undertake engagement with the Stakeholder Group and prepare a draft SOBC and final SOBC for comment and approval by the Cheshire and Warrington Local Transport Body prior to submission to DfT. The appointed consultant will be required to provide appropriate representation at the meetings set out above; assist with engaging key stakeholders, and producing summary meeting notes, and providing weekly progress notes. It is envisaged that most of the meetings will be via Microsoft Teams however meeting rooms will be provided by the client where face to face meetings are required.
Study Management. 21 SECTION IX. SPECIMEN TRANSPORT..........................................22
Study Management. 1. The Quest Protocol Administrator for any Study will interact on a regular basis with the SB Clinical Study Leader or other designated SB contact who shall be specified in each Addendum. Quest shall use its reasonable best efforts to retain such administrator's services for the length of each Study to which they have been assigned, in order to maintain the quality and consistency of Services. In addition, Quest shall provide a qualified back-up to such Protocol Administrator. If such administrator's responsibilities change during the course of an Addendum, Quest shall notify the designated SB contact of such change. Quest shall ensure that the level, quality and continuity of Services are maintained at the levels required by this Agreement despite any changes in personnel at Quest.
Study Management. O Project Administrative Support/Coordination - Int’l (includes support for all functional areas - **** day per month for **** months) Days **** **** **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
