DOCS Operations Manager
About the role
This vacancy has now expired. Please see similar roles below...
This is an exciting opportunity to join ICON- DOCS
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
The focus of this position is to functionally manage the operational aspects of the Global Clinical Development Operations, managed trials through oversight and management of the G-CTAs (Study-facing). Responsibility for capacity management and resourcing of tasks associated with trial start up, execution or close out in all phases of clinical trial development. The range of tasks may vary to some degree depending on the therapeutic area and trial specific requirements.
The Role
- Line manages all assigned G-CTA (Study-facing) as per requirements of role, including performance management.
- Ensure G-CTA (Study-facing) resources are identified and assigned as necessary to support Janssen clinical trials.
- The G-CTA Program Lead and Janssen FM will define resource needs/requirements and interact with G-CTA FM to review current situation per portfolio.
- Partner with G-CTA Program Lead to assign G-CTAs (Study-facing) per needs of the Janssen portfolio (i.e., G-CTA (Study-facing) work assignments, workload requirements and distribution and delegation of tasks to the supporting G-CTAs (Central)).
- Support G-CTA (Study-facing) delivery of trial and/or activity-specific milestones on time and within budget with quality and in compliance with all relevant SOPs, policies and applicable regulatory requirements (G-CTA FM will be trained on all relevant Janssen SOPs)
- Support operational and process definition for the function. Partner with G-CTA FMs and G-CTA Team Leads (TL) to identify, interview, on-board, and train staff per company-specific standards/expectations and trial specific requirements.
- Support inspection readiness activities. Align with Janssen-led activities to coach G-CTA (Study-facing) on their possible role in inspections and any necessary follow-up activities which could result in a Corrective And Preventive Action (CAPA).
- Ensure G-CTA (Study-facing) have a clear understanding and knowledge of GCO SOPs, Work Instructions (WI) and Instructions For Use (IFU) supported by documentation of training compliance in Janssen's training and learning system.
- Track all training metrics and follow-up with employees who are out of compliance. As necessary, and in partnership with G-CTA Program Lead, G-CTA FMs and G-CTA
- Team Leads and/or central team leadership, suggest and implement solutions to problems with study timelines, schedules, resources, etc. Take corrective action where necessary.
- Support the G-CTA (Study-facing) to ensure quality of work deliverables assigned meets requirements as defined in the Quality Oversight Plan agreed with Janssen.
- Manage DOCS Operational deliverables to requirements as designated by agreed program key performance indicators and the operational metrics.
- Track all operational metrics and quality plan deliverables and report at least monthly to G-CTA Program Lead or as required by program requirements.
- Ensure G-CTA (Study-facing) align with trial/program-specific Goals and Objectives (G&O) as they apply to their scope of responsibilities and accountability.
- Manage all organizational aspects of staff management as required by DOCS systems and processes.
- Ensure client and DOCS operational systems are current and accurate all times to facilitate accurate reporting, analysis and business operations.
What you need
- Ability to manage the workload and capacity of G-CTA (Study-facing) locally and in coordination globally.
- Ability to motivate others and enhance performance through excellent, clear and concise communication of goals and expectations.
- Strong, confident communication and presentation skills (client facing and internal)
- Experience in identifying and hiring staff to fulfil role.
- Ability to train and mentor others.
- Ability to work cross-functionally to meet business objectives.
- Flexibility in changing priorities
- Excellent organizational, written and verbal communication skills (English) and the ability to work independently within a global, virtual team environment.
- Excellent independent time management skills.
- Proven ability to plan and track deliverables and timelines.
- Excellence in providing quality work and being detail oriented.
- Bachelor's degree with prior line management and clinical experience preferred. However,
- other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Inside ICONContent type
BlogsPublish date
04/18/2024
Summary
Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis
Teaser label
IndustryContent type
BlogsPublish date
04/18/2024
Summary
Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials
Teaser label
IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Who we are
Similar jobs at ICON
Salary
Location
US, San Antonio, TX, IDS
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
San Antonio
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Early Phase Services
Job Type
Temporary Employee
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR115769
Expiry date
01/01/0001
Author
Alexis HenryAuthor
Alexis HenrySalary
Location
Poland, Warsaw
Department
Full Service - Development & Commercialisation Solutions
Location
Sofia
Warsaw
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR117038
Expiry date
01/01/0001
Author
Kelly BeethamAuthor
Kelly BeethamSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109942
Expiry date
01/01/0001
Author
Christopher BaseliceAuthor
Christopher BaseliceSalary
Location
Ireland, Dublin
Department
Full Service - Corporate Support
Location
Dublin
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Corporate Support
Job Type
Permanent
Description
Job Advert PostingAt ICON, it’s our people that set us apart.As a global provider of drug development solutions, our work is serious business but that doesn’t mean we can’t have fun whilst we do it.Wi
Reference
JR119117
Expiry date
01/01/0001
Author
Maya KatsarskaAuthor
Maya KatsarskaSalary
Location
Poland, Warsaw
Department
Full Service - Biometrics
Full Service - Early Clinical and Bioanalytical Solutions
Location
Budapest
Warsaw
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Medical Data Review
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR117664
Expiry date
01/01/0001
Author
Caroline LockAuthor
Caroline LockSalary
Location
Canada, Montreal
Department
Clinical Trial Management
Location
Canada
Montreal
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109931
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica Hawkins