Clinical Research Manager
At Johnson & Johnson,we believe health is everything.
Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/.
This Clinical Research Manager will be responsible for clinical trial management within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
* Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
* Has oversight of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
* Manages and oversees ordering, tracking, and accountability of investigational products and trial materials;
* Ensures applicable trial registration (e.g.
www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
* Is responsible for team's interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel;
* Is responsible for clinical data review to prepare data for statistical analyses and publications;
* May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
* In EMEA, responsible for Regulatory Affairs related tasks associated with clinical trials and evidence generation.
* Contribute to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g.
Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), ensuring cross-functional alignment;
* Ensures input and strong alignment from key regional Clinical R&D leads and other strategically important countries/ regions in the development of the EGS/ EDS;
* Leads in study design to develop appropriate clinical trials to meet the clinical evidence needs;
* May provide ...
- Rate: Not Specified
- Location: Capital Region-Diegem, BE-VBR
- Type: Permanent
- Industry: Finance
- Recruiter: Johnson and Johnson
- Contact: Not Specified
- Email: to view click here
- Reference: 2406209964W
- Posted: 2024-09-04 08:13:56 -
- View all Jobs from Johnson and Johnson
More Jobs from Johnson and Johnson
- Chief Information Officer
- Category Buyer, Mobile Equipment
- Capital Procurement Manager
- Warehouse/Forklift Operator
- Area Process Improvement Leader - Manufacturing
- Electrical/Mechanical Technician
- Stacker Operator
- Stacker Operator
- Environmental, Health and Safety Coordinator
- Customer Account Coordinator
- Production Supervisor - 2nd Shift
- Sr. Developer Enablement Manager
- Financial Operations Analyst - HYBRID
- Medicare Broker Sales Manager, Licensed - East TN - Remote - Cigna Healthcare
- Business Analytics Manager - Clinical/Healthcare Analytics - Remote
- Consult Staff Pharmacist - Indiana
- Post-Acute Care Provider Relations Advisor - EviCore
- Infrastructure Engineering Senior Advisor- Threat and Vulnerability Management
- Customer Service Representative - Work from home- Accredo
- CareAllies Network Ops Senior Analyst - Hybrid: Huntsville, AL - Cigna Healthcare