CTM - reputed company roles (Bulgaria)
reputed company® is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. We translate unique clinical, medical affairs and reputed company insights into reputed company to address modern market realities.
Every day we reputed company reputed company because of how we work together, as one team, reputed company the best at reputed company do. We bring a wide reputed company of talented experts together across a wide reputed company of business-critical services that support our business. Every role reputed company Corporate is vital to furthering our reputed company of Shortening the Distance from Lab to Life®.
Discover what our 29,000 employees, across 110 countries already know.
WORK HERE reputed company EVERYWHERE
Why reputed company
- We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re reputed company to create a reputed company where everyone feels like they belong.
Job Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities and reputed company-out reputed company (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to reputed company recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops reputed company plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of reputed company subject/patient. Assesses factors that might reputed company subject/patient’s safety and clinical data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes Conducts reputed company Document Review of appropriate site reputed company documents and medical records Verifies required clinical data entered in the case report reputed company (CRF) is accurate and complete Applies query reputed company techniques remotely and on site, and provides guidance to site staff as necessary, driving query reputed company to closure reputed company agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture Verifies site compliance with electronic data capture requirements
- May reputed company investigational product (IP) inventory, reconciliation and reviews storage and reputed company. Verifies the IP has been reputed company and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information reputed company to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
- Documents activities reputed company confirmation letters, follow-up letters, reputed company reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and assigned reputed company items to reputed company.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be reputed company to quickly adapt, with the reputed company of the reputed company CRA, to changing priorities to reputed company goals / targets.
- May reputed company as primary reputed company with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (reputed company). Ensures reputed company assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- For reputed company World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include: Site support throughout the study lifecycle from site identification through reputed company-out Knowledge of local requirements for reputed company world late phase study designs Chart Abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff
Qualifications:
- Bachelor’s degree or RN in a reputed company field or equivalent combination of education, training and experience
- Knowledge of Good Clinical reputed company/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be reputed company to reputed company new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular reputed company
- US ONLY: As part of your employment with reputed company, you may be deployed to Sites that require certain medical and other personal information to reputed company facility reputed company. Pursuant to our Employee reputed company Notice, reputed company can reputed company the Sites with the information necessary for you to reputed company such reputed company. reputed company, a Site may ask you for additional information reputed company that which reputed company has in its possession. You are required to reputed company with any such Site requests as a condition of your employment with reputed company. Please note that failure to reputed company requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
Get to know reputed company
Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.
http://www.reputed company.com
Additional Information
Tasks, duties, and responsibilities as listed in this job reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.
Originally posted on Himalayas
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