Creative Pharma & HR Services
Creative Pharma & HR Services Chalandri Greece
1 month ago
Coordinates and executes regulatory submissions in accordance with the applicable contract terms, ICH GCP guidelines, SOPs and national/international regulations. Carries through activities related to Scientific Events and Advisory Boards and ensures timely execution of scientific engagements. Closely collaborating with other functions and ensures full alignment to meet timelines, key activity milestones and high-quality deliverables of projects involved.
• Responsible for contacting clients, developing proposals / offers and developing contracts for given projects.
• Establish customer service relationship with applicable client representative(s), as appropriate
• Adhere to ICH Good Clinical Practice (GCP) guidelines, Codes and Policies and in accordance with Standard Operating Procedures (SOPs) and contractual requirements of clients
• Execute and coordinate the collection and preparation of documents (such as clinical trial applications) for regulatory start-up... submissions of clinical studies
• Compile the submission folder for regulatory and statutory submissions
• Maintain and cultivate professional relationships with the Ethics Committees, Regulatory agencies and other institutions regarding submissions and approvals of clinical studies and other scientific engagements
• Track submissions and update tracking systems accordingly
• Track, distribute and file documents, as appropriate
• Prepare or review invoices against signed contracts and approved budget
• Attend project meetings and interact with clients, when required
• Attend team meetings, keep meeting minutes and distribute them to the team
• Create and maintain project/study contact lists for project/study teams and sites, where applicable
• Administer and handle scientific events (Advisory Boards, Educational Events, Satellite Symposia etc. either Face to Face, web-based or hybrid), communicate with sponsors, Health Care Professionals & competent authorities, contract management until approval & process finalization, invoice issuance and payments. Organize/ set up the event (room booking, hotel accommodation, transfers, food & beverages)
• Provide input during creation, update, and maintenance of policies and procedures related to area of expertise and role
• Contribute to the development of SOPs and other company initiatives, as required
• Bachelor’s Degree in related field or equivalent (Health related field preferable)
• At least 2 years of work experience in clinical studies and scientific engagement
• Working knowledge of current related regulations
• Strong interpersonal, communication, organizational and problem-solving skills
• Fluency in the written & spoken English language
• Computer skills (Word Processing, Spreadsheet, Database management applications)
• Experience in Submissions of Clinical Trials in CTIS according to CTR will be considered an extra asset
What we offer
Creative Pharma & HR Services is offering a competitive remuneration package according to the industry’s standards. Nonetheless, we are also proud at Creative Pharma & HR Services that we are an open and learning organization that fosters a collaborative, enthusiastic, fast paced working environment, and for that reason we invest in people’s potential and growth.
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Senior Clinical Start Up Officer Chalandri jobs
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