JOB DESCRIPTION:

Accountabilities for the role of the MDRL

• Primary point of contact for all aspects related to the management of the outsourced Medical Data Review services;


• Ensure that the services meet the expectations both in terms of quality and timelines. (Manages project timeliness, quality, scope, budget and risks (minimization/mitigation) for all activities in a project);


• People management of vendor’s medical reviewers, includes but not limited to day-to-day management of people, coaching and mentoring, performance management;


• Coordinates project activities with project teams members and ensures that all project team members are aligned with governance strategy and the project management plan;


• Identifies quality issues within the project and put in place appropriate corrective action or action plan;


• To manage the vendor’s medical review resources This covers the following activities: evaluation/review of need for additional resources, transfer of resources from one project/study to another, hiring of new MDR's;


• Responsible for achieving successful delivery of all activities in the conduct of projects across all therapeutic areas;


• Ensures compliance to relevant SOP’s and compliance to appropriate regulations (ICH-GCP, local regulatory requirements.).

REQUIRED SKILLS AND EXPECTED LEVEL:

• The MDRL role must be a senior profile, trained in the requirements to the execution of the Services and regulatory requirements such as GCP and ICH guidelines, and with extensive experience in clinical trials;


• The entitled MDRL has proven project and people management as well as strong leadership skills;


• Ideally, should have an experience in Medical Data Review or/and Data Management area;


• Perfect knowledge of current office tools (Excel, Word, Power Point);


• Strong management skills and leadership;


• Fluent in English (spoken and written);


• Organized, pro-active and autonomous;


• Attention to detail;


• Strong interpersonal skills;


• Strong oral and written communication skills;


• Problem Solving – Can assimilate information and ideas from a wide source to make high quality decisions. Takes a broad overview of the situation / problem or event.

REQUIRED LEVEL OF EDUCATION:

• Master degree in life science, or equivalent acquired experience;


• Area of specialization: Life sciences or Biomedical Sciences, Clinical Research, Data management.

REQUIRED WORK EXPERIENCE IN THIS ROLE:

• Experience in Medical Data Review/Data Management activities;


• Minimum of 3 years of experience in Project Management or certified training in Project Management;


• Experience in managing and coaching more junior colleagues in projects.

Location: Waterloo - Hybrid

WHAT WE OFFER:

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

WHO WE ARE:

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.