- Talented and Experienced Medical Reviewers with Potential to Grow Global Development (GD) Global Service Centre (GSC).
- Are you a looking forward to take your career to the next level and give your career a new direction?
- Join GD GSC Centralized Monitoring Unit (CMU) Support at our company to get a life-changing career and make a difference to thousand lives!!
About the department
- GD GSC was started in September 2007 and within a short span of nine years since its inception, has transitioned from a small start-up to one of the largest units in GSC and a key contributor to company clinical development portfolio.
- As the organization is growing along with the R&D portfolio, we are looking for several new medical Reviewing colleagues. Join us and you will work with dedicated specialists from around the world in a growing organisation. We offer unique opportunities with a significant amount of individual responsibility and an important role in our evermore imperative work of bringing new and better treatments to the market.
- In Global Development, we are responsible for managing clinical drug development worldwide from early development phases to product introduction.
- The CMU support is established in GSC to support the risk based monitoring of clinical trials conducted by our company in line with health authority requirements. The unit is responsible for performance of centralized medical review of patient data that includes Medical Consistency Checks (MCC), medical monitoring and lab surveillance; and generation of visualizations and reports identifying outliers and trends from various data sources.
- You will join a team of ~20 highly skilled medical reviewers and functional programmers who as a unit had a steep learning curve and took their first initial assignments within their first quarter of its inception in GDGSC.
The position: Associate Medical Reviewer
Main Job Requirements
Responsible for study activities regarding Medical Review to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, local regulations and SOPs
- Attend study-specific training for assigned trials, as appropriate
- Collaborate with the Data Manager, Trial Manager(s) and Medical specialists to obtain/share trial specifics issues relating to medical review across all responsible study sites concentrating on areas related to data quality
- Consult with Trial Managers and Medical Specialists as appropriate to ensure medical review issues are escalated in a timely manner
- Ensure data integrity (adhering to blinding plan), patient safety and regulatory compliance for assigned activities of medical review within assigned studies
Responsible for Medical Review of all assigned clinical studies and for identifying issues of medical concern and/or inconsistency in the clinical trial data and ensure alignment within project/trial
- For trials using Risk Based Monitoring methodology Medical Review includes medical monitoring focusing on eligibility, medication history and withdrawal/discontinuation for protocol compliance; potentially clinically significant outliers that needs medical attention and medical cleaning for data consistency at subject level.
- For trials not using Risk Based Monitoring the main focus on Medical Review is medical consistency check (MCC) and where decided early eligibility check
- For both types of trials, Medical Review includes, but is not limited to:
- Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy and medical consistency Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages Review all reported Adverse Events (AEs) to ensure all supporting information is expected and/or implausible data is verified. Review all reported Concomitant Medications to ensure no medication is disallowed per protocol, supports an existing reported medical condition or is prescribed for a reported AE Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial Ensure proper end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending participation in the clinical trial Review all laboratory results to ensure completeness of information supplied, adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient Review all patient reported medical history information to verify completeness of reported information, adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
- Review additional information, as necessary, to determine overall readiness of the patient information for next level review Review all supplied Line Listings, patient profiles to determine data accuracy across patients within a specified group of data points
Responsible for high quality medical data through medical review of clinical trial data
- Develop good understanding of relevant protocol and trial specific manuals/plans to ensure quality deliverables
- Develop good therapeutic knowledge and general understanding of diseases and treatments as well as the latest medical developments
- Stay updated on training as required for the role as well as individual competency development
- We cover all clinical development projects within company’s different therapy areas, and the focus and daily tasks depend on the life cycle stage of the project. Planning and coordination of activities in a cross-disciplinary setting is also a central part of the job, and we expect that you are capable of ensuring high quality medical data through the medical review and manage the involved stakeholders.
- The job is globally oriented and requires close collaboration with colleagues in other skill areas both in India and Denmark.
- You have a medical degree (MD, MBBS ) including skills of use of document management systems, Adobe Acrobat Professional and MS tools: Outlook, Excel, Word, and PowerPoint. Preferably you have good knowledge on ICH-GCP.
- You should have the ability to communicate, plan and coordinate multiple simultaneous activities.
- You are a strong team player who adapts easily to a changing environment with tight deadlines, and you are good at planning, coordinating and reaching consensus.
Working with Us:
- At our company Research & Development, GD GSC, our trust in our employees has always been one of the cornerstones of the way we work.
- Working here, you’ll be part of a team of the best and brightest in your field, where scientific integrity is standard and shared responsibility taken for granted.
- We use our skills, dedication and ambition to make a change in the lives of many people with chronic diseases in our own way.
- You will get the opportunity to take part in this, and in addition enhance your career, benefiting from the possibilities for professional and personal development provided by our company.