4 Clinical Operations Lead II Jobs in Edison, NJ

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Lead Warehouse Operations Associate

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Edison, NJ | Full Time

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Clinical Operations Lead II

Sunrise Systems

Edison, NJ | Full Time

$70k-89k (estimate)

2 Weeks Ago

Clinical Operations Lead II

Sunrise Systems Edison, NJ

$70k-89k (estimate)

Full Time 2 Weeks Ago

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Sunrise Systems is Hiring a Clinical Operations Lead II Near Edison, NJ

Job Title: Clinical Operations Lead II
Job ID: 24-02424
Location: Remote
Duration: 12 months (possibility of an extension) on W2 contract
Job Description:
Must Haves:

OP Lead or Trial Management experience (NOT looking for clinical trial managers)
Must have lead experience (Preferred 6 years, Minimum to be considered 4 years)
Ophthalmology experience
Medical Device or Pharma experience
This is a global role - candidate could be assigned to clinical trials outside of the U.S. so candidates working hours should be flexible. (I.E. Starting earlier or later as needing to meet with partners)

The Clinical Operations Lead is responsible for performing project management tasks at country, regional and site level in support of planning, conduct and reporting of clinical trials. This person should ensure trial conduct is efficient, with seamless execution, achievement of timelines and study deliverables with quality, and full compliance with international guidelines, local regulations and corporate policies and procedures.
Major Responsibilities:

Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of 2-3 clinical trials of low to medium complexity in support of one or more projects.
Provide operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, and other documents as required.
Develop Protocol Monitoring Plan (PMP).
Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, achievements, and status of CSM activities.
Prepare, coordinate, deliver, and track protocol specific training for CSMs and site personnel.
Initiate Investigational Product shipment requests, resupply, and coordinate reclamation of supplies from sites for assigned trial(s).
Create and maintain user account worksheets for provisioning all site personnel for assigned trials into required systems (e.g., EDC, IRT, training portals).
Proactively identify potential/actual issues and risks, bring up to management as appropriate, and contribute to mitigation.

Competency Profile:

Customer Focus
Action Oriented
Collaborates
Communicates Effectively
Plans & Aligns
Problem Solving

Preferred Qualifications:

Bachelor's Degree in life science; medical, pharmaceutical, biology, chemistry degree preferred.
The ability to fluently read, write, understand and communicate in English.
5 years of direct experience as Clinical Operations Lead or clinical trial management experience.
Travel requirements: 5-10% (paid for by the client)
Field clinical monitoring, site management (e.g., study coordinator), or clinical research experience
Project Management experience preferred
Excellent verbal and written communication, problem solving skills and team orientation

Major Accountabilities

Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of clinical trials within CDMA. Each Clinical Operations Lead will be assigned 2-3 clinical trials of low to medium complexity in support of one or more projects.
Successful implementation and execution of assigned trial(s) in compliance with guidelines, regulations, and procedures.
Ensure consistency of Alcon's processes and procedures across sites and studies
Contribute operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, etc.
Develop Protocol Monitoring Plan (PMP)
Follow study metrics using all available tools, systems and information (e.g., CTMS, EDC, CDM reports) to ensure achievement of target study milestones and deliverables.
Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, milestones, and status of CSM activities.
Coordinate study activities with assigned CSMs, reinforcing compliance with PMP, relevant procedures, and applicable regulations.
Coordinate, prepare, deliver, and track protocol specific training for site personnel and assigned CSMs.
Initiate Investigational Product shipment requests, resupply and coordinate reclamation of supplies for sites on assigned trial(s)

Create and maintain user account worksheets for provisioning all site personnel and CTT members for assigned trials into required systems (e.g. EDC, IRT, training portals)
Actively participate on the Clinical Trial Team (CTT), building relationships and serving as liaison among trial team personnel as appropriate
Facilitate communication between CTT and sites throughout the trial.
Provide progress reports to CTT and upper management routinely.
Proactively identify potential/actual issues and risks, escalate to CTT and management as appropriate, and contribute to mitigation.
Leads/participates in department and cross-functional process improvement initiatives to improve operational efficiencies.

Achievement of project specific milestones for assigned trials as defined in overall CDMA objectives:

First Patient First Visit (FPFV), Last Patient First Visit (LPFV), Last Patient Last Visit (LPLV), and Database Lock (DBL)
High quality/compliance in assigned trials as defined in overall CDMA objectives
Adherence to processes and procedures
Proactive identification and mitigation of issues/risks
Competency Profile
Customer Focus
Action Oriented
Collaborates
Communicates Effectively
Plans & Aligns

Contact:
Durga Prasad: Durgaprasad.B@sunrisesys.com | 732 313 0251 | URL: www.sunrisesys.com
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