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Job Details

Clinical Affairs Manager

Location
Kalamazoo, MI

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Job Description
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
How You Will Make an Impact
The Clinical Affairs Manager (CAM) is responsible for all aspects of clinical trial including key data management activities in compliance with GCP’s, SOPs and standards within established timelines and budgets.The CAM is involved in the scientific conduct of the study and works together with operational disciplines to guarantee release of homogeneous high quality data. The CAM is also responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. The CAM must be comfortable working independently, managing interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders. The CAM ensures trial(s) are managed to the highest quality to strive for safety and effectiveness of Sanofi products. May be required to take on the Dedicated Project Expert (DPE) role depending on business needs.
What You Will Do
Provide oversight of a study to ensure progress according to study timelines
Ensure proper collection and validation of data and documentation on a timely manner
Organize and lead study specific meetings
Collect, synthesize and report study information
Collaborate with the Clinical Supplies Platform to validate IMP needs, specifications, packaging, shipment (including resupply) and reconciliation process
Participate in selection and management of vendors,
development/follow-up
of the associated budget
Preparation and oversight of study audits/inspections both internal and external
Provide oversight and preparation for FDA pre-approval inspections (PAI)
Participate in the training of new CAMs on therapeutic area and general responsibilities within their function.
How You Will Get Here
Bachelor's degree plus at least 3 or more years of experience in pharmaceutical industry or clinical-related discipline including at least 2 years clinical research experience.
Demonstrated ability to act as CAM lead, leading the study team and being able to efficiently work with other CAM’s in the same study
Experience in managing and leading international meetings (e.g. Study Teams)
Ability to anticipate, timely escalate issues and to define appropriate action plans
Capability to challenge
decisions/status-quo/requests
using risk management approach (e.g. unrealistic timelines, unplanned database snapshot.
Display stakeholder management skills (e.g. ability to manage expectations).
Strong organizational, project management and presentation skills
Ability to develop and maintain an optimized study planning with other functions (including identification of critical path)
Ability to handle multiple tasks, prioritize his/ her activities and to drive the team accordingly
Ability to coordinate multiples interfaces: Complex studies including several vendors, external non-standard data (e.g. Complex biomarkers, imaging, etc.)
Ability to anticipate, timely escalate issues and to define appropriate action plans
Ability to work autonomously, to efficiently and effectively provide status reports
Capability to routinely perform data management activities and oversight, data review and analysis (clinical & operational) to propose actions and a remediation plan
Ability to appropriately delegate responsibilities (e.g., Internally - when several CTMs involved on a study/ Externally - in case of outsourced activities)
Ability to adapt his/ her communication, address the right topics and adapt content/level of details to the right recipients, select topics to be addressed internally first
Encourage collaboration and communication within and beyond the team
Provide action plans for decision making
Make decisions when needed and take responsibility (accept accountability for results, even if the outcomes are difficult or sensitive)
Experience in the management of vendors for outsourced activities
Ability to effectively interact with scientists and managers within and outside CSO SCP, serving as internal consultant on assigned area (e.g. Subject Matter Expert) and liaise with external organizations on projects
Ability to work in an international environment with internal and/or external partners (e.g vendors, database designers, programmers)
Ability to adapt and be flexible to change, managing internal and external challenges & opportunities
Knowledge of industry data management standards and practices
Knowledge or ability to rapidly gain knowledge with programming/query languages
Understanding of data base concepts
Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems, processes and SOPs)
At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today
****Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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