דרושים » רפואה ופארמה » CTC/Sr CTC - FSP - EMEA

we are looking for a CRA I/II - FSP.
What Youll Do:
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
Participates in investigator meetings as necessary. Identifies potential
investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required.

we are looking for a Manager, Medical Writing (Publications).
As part of our expert team, youll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Manager Medical Writing, you will manage the performance and workload of Medical Writers and provide short-term and long-term resource planning to assign projects to appropriate and available staff. You will supervise the preparation of Medical Writing deliverables and organize processes for the completion of projects within established timelines. You will evaluate the timeliness and quality of deliverables. You will assist writers in the presentation and interpretation of data and perform senior reviews to ensure overall adherence to departmental standards. Additionally, you will participate in the preparation and review of group SOPs and WPDs, evaluating compliance with SOP/WPD on an ongoing basis. You will give marketing presentations to potential clients on the capabilities of the Medical Writing department and interact with Bids and Contracts and Business Development to prepare budgets and proposals for Medical Writing projects. You will also participate in the development of training programs for Medical Writing and ensure direct reports are adequately trained.
What Youll Do:
Supervises Medical Writers. Provide short-term and long-term resource planning in order to assign projects to appropriate and available staff. Holds regularly scheduled meetings with staff and provide updates to senior management. Review and approve semimonthly time sheets. Assist staff to forecast project-related costs and timelines for completion. Hires and evaluates employees. Recommends salary levels and promotions
Supervises the preparation of Medical Writing deliverables. Organizes processes for completion of projects within established timelines. Evaluate timeliness and quality of deliverables and provides updates to senior management. Acts as resource for questions relating to study design, adverse event reporting, and statistical analyses. Assists writers in presentation and interpretation of data. Performs senior review to ensure overall adherence to departmental standards. Write and review group SOP and WPD. Evaluates compliance with SOP/WPD on an ongoing basis. Stays updated on relevant publication guidelines and requirements (GPP, ICMJE, etc.)
Gives marketing presentations to potential clients on the capabilities of the Medical Writing department. Interacts with Bids and Contracts and Business Development to prepare proposals for Medical Writing projects.
Develops and maintains training programs for Medical Writing. Ensures that all writers are adequately trained.
Uses scientific knowledge to assist in the written interpretation of scientific data and to guide others in their presentation of scientific data.