Manager, Clinical Project Scientist
2 weeks ago
Johnson & Johnson Innovative Medicine is recruiting for a Manager, Clinical Project Scientist to be located in Horsham, PA.
This individual contributor will be a part of the US Medical Affairs Immunology Clinical Operations & Program Management Team and support one to two therapeutic areas. The Manager, Clinical Project Scientist, is responsible for successful implementation of the Investigator Initiated Study (IIS) program as well as company sponsored trials, collaborative studies and post marketing commitment studies, including both interventional, non-interventional and registry studies. In this role, the individual will work closely with the Therapeutic Area Lead, the Medical Directors (Study Responsible Physicians) responsible for individual assets, the Medical Science Liaison (MSL) team, and Global Development Medical Affairs Delivery Unit (GD MADU) to review submitted IIS proposals and execute, track, manage and oversee approved IIS protocols. He/she will work with the Medical Directors, MSL team, and GD MADU to ensure that IIS trials are executed in a timely and compliant fashion to deliver data to support evidence generation needs in the US.
This individual will also work closely with the Study Responsible Physicians and Research Scientists for US Medical Affairs sponsored studies, to ensure that these company sponsored studies and collaborative studies are conducted and executed in a timely manner. A key responsibility will be review and coordination of all project-related documentation, leading the Steering Committee process with SRPs, completing user acceptance testing of systems and leading Lessons Learned Meetings. As a leader on the Study Team, this individual will identify issues and potential operational hurdles within a project and propose options for resolution in coordination with the Study Responsibility Physician, Study Responsible Scientist and Global Trial Leader(s). This individual is the main point of contact for GD MADU for studies.
Interfaces with multiple scientific partners related to planning and strategy for therapeutic area trials and publication strategy. Interfaces with insourced and outsourced trial execution resources within the GD MADU organization. Considered by peers as a clinical trials expert, technically proficient, intelligent, and results oriented. Able to think creatively, critically, and proactively, with strong problem-solving skills. Collaborative and flexible in personal interactions at all levels of the company. This individual will interface regularly with both internal and external stakeholders and vendors.
Major Responsibilities:
Clinical Project Scientist for assigned company sponsored, collaborative, post marketing and registry Trials including but not limited to:
- Actively contribute to protocol planning and development and case report forms
- Prepare agendas and meeting minutes for study meetings and lessons learned meetings
- Review study plans and provide feedback to GD MADU
- Develop study trackers (i.e., enrollment tracker, Steering Committee tracker)
- Assist with user acceptable testing for clinical trial systems
- Prepare presentations and reports for leadership
- Issue identification and resolution and proactive risk mitigation
- Lead the preparation and scheduling of Steering Committees, Data Safety Monitoring Boards and Investigator Meetings under oversight of the SRPs
- Key liaison (primary point of contact) with our GD MADU partners and other scientific and business-related disciplines (e.g., R&D, Clinical Supplies, QA, etc.)
- In concert with medical/clinical personnel, the Clinical Project Scientist assists with execution of clinical studies; interpretation of results; preparation of oral and written internal/external presentations; development, management, and tracking of trial budgets; and budget and contract development with third party vendors
- Assist with tracking and managing adverse event data collection across trials; and where appropriate, incorporation into obligatory regulatory documents
Clinical Project Scientist for TA IIS program including but not limited to:
- Collaborates with TA lead, Medical Directors and counterparts in GD MADU to develop strategic IIS guidance documents and support IIS projects across the portfolio
- Serve as the primary liaison between J&J Innovative Medicine and Clinical Investigators
- Manages monthly/periodic meetings to monitor and update organizational logistics of IIS proposal intake, review, and tracking
- Actively review and provide feedback per SOPs for protocols and Informed Consents
**Qualifications**:
Education
Bachelor’s Degree is the minimum requirement, preferably in Life sciences and/or business management. Advanced degree in life sciences or business management is preferred
Experience and Skills
Required:
- Five+ years of industry experience; including a minimum of two years in clinical trial project management/operations experience working in Clinical Trials Phase I
-
Clinical Laboratory Scientist
3 days ago
Horsham, United States Medix Full timeWe are looking for an entry level scientist to join and exciting and rapidly growing biotech company! Interested applications must have an Associates of Science degree or higher in Biology, Chemistry, Physical Science or Medical Technology. Shift: 100% on site, 3pm-11pm 4 weekdays + Saturday (Saturday shift is 9am-5pm) Pay: $24-$26hr Job Description: The...
-
Clinical Laboratory Scientist
5 days ago
Horsham, United States Medix™ Full timeWe are looking for an entry level scientist to join and exciting and rapidly growing biotech company! Interested applications must have an Associates of Science degree or higher in Biology, Chemistry, Physical Science or Medical Technology. Shift: 100% on site, 3pm-11pm 4 weekdays + Saturday (Saturday shift is 9am-5pm)Pay: $24-$26hrJob Description: The...
-
Horsham, Pennsylvania, United States Johnson & Johnson Full timeJohnson & Johnson is currently seeking an Associate Director, Clinical Scientist to join our world-class Medical Affairs Gastroenterology Therapeutic Area Strategy Team located in Horsham, PA. Are you an ambitious Clinical Scientist looking to take your career to the next level? In this role, you will have the opportunity to work on groundbreaking projects...
-
Manager, Safety Analysis Scientist
3 weeks ago
Horsham, United States Johnson & Johnson Full timeThe Manager Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The Manager SAS, in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related...
-
Manager, Safety Analysis Scientist
3 weeks ago
Horsham, Pennsylvania, United States Johnson & Johnson Full timeThe Manager Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The Manager SAS, in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related...
-
Program Manager
2 weeks ago
Horsham, United States CareerBuilder Full timedaily coverage of the optics & photonics industry and the markets that it serves Avo Photonics , Horsham, PA, United States Employer Description Avo Photonics (www.avophotonics.com ) is a dynamic contract engineering services company that designs, develops and manufactures custom opto-electronic products for a large customer base. Members of our staff have...
-
Project Manager
2 weeks ago
Horsham, United States CareerBuilder Full timeTrumbull Corporation has immediate openings for Heavy Civil/Highway Construction Project Managers in the Central and Eastern Pennsylvania regions. About Trumbull: Best-in-class leader in heavy civil and highway construction Consistently ranked a Top 100 Contractor by Engineering-News Record Has been building infrastructure projects in Central and Eastern...
-
Project Manager
2 weeks ago
Horsham, United States PJ Dick-Trumbull-Lindy Group Full timeTrumbull Corporation has immediate openings for Heavy Civil/Highway Construction Project Managers in the Central and Eastern Pennsylvania regions. About Trumbull: Best-in-class leader in heavy civil and highway construction Consistently ranked a Top 100 Contractor by Engineering-News Record Has been building infrastructure projects in Central and Eastern...
-
Program Manager
1 week ago
Horsham, United States Avo Photonics Full timeAvo Photonics (www.avophotonics.com) is a dynamic contract engineering services company that designs, develops and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to design, prototype, and produce next generation products for a diverse range of markets including environmental, medical,...
-
Program Manager
23 hours ago
Horsham, United States Avo Photonics Full timeAvo Photonics (www.avophotonics.com) is a dynamic contract engineering services company that designs, develops and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to design, prototype, and produce next generation products for a diverse range of markets including environmental, medical,...
-
Program Manager
1 week ago
Horsham, United States Avo Photonics Full timeAvo Photonics () is a dynamic contract engineering services company that designs, develops and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to design, prototype, and produce next generation products for a diverse range of markets including environmental, medical, military, industrial,...
-
Program Manager
3 weeks ago
Horsham, United States Avo Photonics Full timeAvo Photonics (www.avophotonics.com) is a dynamic contract engineering services company that designs, develops and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to design, prototype, and produce next generation products for a diverse range of markets including environmental, medical,...
-
Learning Manager, Sales Learning
1 week ago
Horsham, Pennsylvania, United States Johnson & Johnson Full timeAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
-
Scientific Project Manager
3 weeks ago
Horsham, United States Tekwissen Full timeResponsibilities Maintain audit and inspection master schedule with regular updated information Coordinate audit scheduling prepare and confirm subject matter expert (SME) lists plan audit logistics etc Manage pre-audit requests for information and respond to incoming queries during inspections and audits and ensure timely and accurate responses....
-
Scientific Project Manager
3 weeks ago
Horsham, Pennsylvania, United States Tekwissen Full timeResponsibilities Maintain audit and inspection master schedule with regular updated information Coordinate audit scheduling prepare and confirm subject matter expert (SME) lists plan audit logistics etc Manage pre-audit requests for information and respond to incoming queries during inspections and audits and ensure timely and accurate responses. Triage and...
-
Medical Director, Rheumatology Therapeutic Area
2 weeks ago
Horsham, Pennsylvania, United States Johnson & Johnson Full timeJohnson and Johnson is recruiting for a Medical Director, Rheumatology Therapeutic Area in our US Immunology Medical Affairs organization located in Horsham, PA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments...
-
Project Engineer
3 weeks ago
Horsham, United States PJ Dick Full timeProject Engineer (Heavy Civil/Highway Construction) Take advantage of an opportunity to work for an industry leader! Trumbull Corporation has immediate openings for Heavy Civil/Highway Construction Project Engineers in the Central and Eastern Pennsylvania regions. About Trumbull: Best-in-class leader in heavy civil and highway...
-
Senior Manager, Product Quality Integrator
1 week ago
Horsham, Pennsylvania, United States Johnson & Johnson Full timeJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Product Quality Integrator-Launch & Grow Biotherapeutics The position can be based at one of the following sites: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, Springhouse or Malvern,...
-
Project Engineer
2 weeks ago
Horsham, United States PJ Dick-Trumbull-Lindy Group Full timeTake advantage of an opportunity to work for an industry leader!Trumbull Corporation has immediate openings for Heavy Civil/Highway Construction Project Engineers in the Central and Eastern Pennsylvania regions. About Trumbull: Best-in-class leader in heavy civil and highway construction Consistently ranked a Top 100 Contractor by Engineering-News Record...
-
Safety Manager
2 weeks ago
Horsham, United States National Glass & Metal Co Full timeJob DescriptionJob DescriptionJob Summary: -Responsible for the policies and procedures that comprise the Company Safety program and protect our employees, customers, partners and the public from injury. This includes evaluating and implementing safety and health hazard controls in the workplace, routine hazard recognition inspection and training of field...
