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Intern Clinical Project Manager Jobs in Florida (NOW HIRING)

Insightec

SR Clinical Project Manager

Miami, FL · On-site +1

Responsible for management of all clinical studies including activities such as but not limited to: * Developing project management plans, strategy, cost and timelines * Identification, qualification ...

Galatea Bio, Inc.

Clinical Data and Project Manager

Miami, FL · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Strong planning and project management skills, with a natural ability to influence collaboration * Practical experience within a Contract Research Organization or as part of a multi-site Clinical ...

Zimmer Biomet

$14 - $18.75/hr

What You Can Expect The Clinical Applications Intern is responsible for providing support to the Biostatistics & Clinical Data Management (BCDM) department in the development and maintenance of ...

Zimmer Biomet

$14 - $18.50/hr

What You Can Expect The Clinical Applications Intern is responsible for providing support to the Biostatistics & Clinical Data Management (BCDM) department in the development and maintenance of ...

Galatea Bio, Inc.

Clinical Data and Project Manager

Miami, FL · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Strong planning and project management skills, with a natural ability to influence collaboration * Practical experience within a Contract Research Organization or as part of a multi-site Clinical ...

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All JobsIntern Clinical Project JobsIntern Clinical Project Manager JobsIntern Clinical Project Manager Jobs in Florida

Intern Clinical Project Manager information

What is the difference between Intern Clinical Project Manager vs Clinical Research Coordinator?

AspectIntern Clinical Project ManagerClinical Research Coordinator
Required CredentialsTypically pursuing or holding a bachelor's or master's degree in life sciences or related fieldUsually holds a bachelor's degree in health sciences or related field
Work EnvironmentAssists in managing clinical trials, coordinating project activities, and supporting project managersManages daily clinical trial activities at research sites, including patient recruitment and data collection
Employer & Industry UsageUsed by pharmaceutical companies, CROs, and biotech firms during early career stagesCommonly employed at clinical research sites, hospitals, and academic institutions

The Intern Clinical Project Manager role focuses on supporting project management tasks within clinical trials, often in a learning capacity, while the Clinical Research Coordinator handles on-site trial activities. Both roles require related educational backgrounds but differ in responsibilities and work settings.

What are the most commonly searched types of Clinical Project Manager jobs in Florida? The most popular types of Clinical Project Manager jobs in Florida are:
Intern Clinical Project Manager jobs near you

SR Clinical Project Manager

Insightec

Miami, FL • On-site, Remote

Full-time

Posted 21 days ago

Job description

Description
Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.
Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values - Our Patients, Integrity, Team, Quality and Innovation.
Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.
Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.
Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.
Responsibilities:
  • Responsible for independently leading the clinical trial study team and managing global clinical trial activities on a pivotal trial or multiple feasibility trials from start-up through study closeout in a manner that manages risk and ensures compliance with the protocol, GCP, and the local governing regulations.
  • Effectively communicates and guides / directs the activities of the clinical team members through all the details of large and complex trials, to include regulatory compliance, high quality data collection, and audit readiness that will lend itself to regulatory process approvals.
  • Partners effectively with R&D, Regulatory, Quality, Marketing/Product stake-holders, supports the regulatory processes with regulatory writing, strategy development, and corrective actions as needed.
  • Responsible for management of all clinical studies including activities such as but not limited to:
  • Developing project management plans, strategy, cost and timelines
  • Identification, qualification, and training of investigators and their teams
  • Contribute to protocol writing/amendments, regulatory deficiencies, annual progress reports, final study reports
  • Responsible for the activities related to IRBs/ECs, and clinical study vendors (e.g.. core lab, statistical consultants, etc.)
  • Develops SAE narratives for DSMB review and manages oversight of the safety profile as per the protocol/stopping rules, local regulations, and IRB.
  • Proactively manage the data management and data lock processes of the clinical trial and takes an active role in the final clinical study reporting process
  • Responsible for great site relationships with the PI and coordinator to establish trust and collaboration between both parties.
  • Ensure annual regulatory reporting is crafted, updated and submitted in a timely fashion.
  • Assist/support preparation of registration packages, and activities requiring regulatory agency approvals
  • Implement solid strategy, scope, process, and programs related to clinical trials including leading SOP creation, guidelines, and work instructions.
  • Effectively communicate scientific information to key stakeholders and support publication activities
  • Provide training on disease, indication, protocol, etc to cross-functional teams as well as external collaborators.
  • Provide leadership in the development of other clinical project managers within the Global Clinical Affairs team as a mentor
  • Provide significant and positive impact to short-term, mid-range, and long-term organizational goals
  • Demonstrate process improvement in product/system development related matters such as electronic data capture, image management and clinical trial management systems
  • Create a work environment that supports cross-functional team effectiveness and promotes efficiencies
  • Contribute to conference abstracts and peer reviewed publications with opportunity to present as applicable.

Requirements
Qualifications:
  • Bachelor's degree in a Life Sciences discipline required; Master's degree or other advanced scientific/clinical qualification preferred.
  • Exceptional proficiency in professional English, with advanced medical and scientific writing skills, including development of clinical protocols, clinical study reports (CSRs), safety reports, annual regulatory reports, informed consent forms (ICFs), case report forms (CRFs), and other regulatory-compliant clinical trial documentation.
  • Demonstrated experience authoring clinical study protocols and contributing to clinical sections of regulatory submissions, including PMA and/or 510(k) applications
  • Strong presentation and communication skills, with experience delivering scientific and clinical information to investigators, key opinion leaders, clinical study teams, senior management, and at Clinical User Meetings.
  • Comprehensive knowledge of the medical device clinical trial lifecycle, from study concept and design through study execution, data analysis, CSR preparation, and regulatory submission support.
  • In-depth understanding of medical device clinical research, including operational, regulatory, and quality requirements, with thorough knowledge of Good Clinical Practice (GCP), FDA regulations, ISO 14155, and applicable global medical device regulations.
  • Solid understanding of biostatistics and clinical data interpretation, with the ability to critically evaluate scientific literature and effectively communicate statistical outcomes in clinical and regulatory documents.
  • Strong business acumen including presentation, verbal and written communication skills as well as negotiation, partnering, and collaboration without direct line management and including regular communications with senior clinical research physicians and scientists.
  • Minimum of 5-6 years of progressive experience in clinical project management, including oversight of IDE, IND, Class III medical device, and/or drug-device combination product studies.
  • Experience working directly with regulatory authorities, including FDA, notified bodies, and international regulatory bodies, supporting study submissions, approvals, and ongoing regulatory interactions
  • Proven ability to manage and oversee external clinical vendors, including contract research organizations (CROs), biostatistical consultants, core laboratories, data management providers, Clinical Events Committees and Data Safety Monitoring Boards (DSMBs).
  • Strong knowledge of U.S., EU, Japan clinical trial regulations and processes; experience with international clinical research regulations and global study execution is highly desirable.
  • Recognized subject matter expertise in regional clinical research regulations and compliance requirements.
  • Excellent organizational, leadership, and stakeholder-management skills, with the ability to manage multiple complex projects in a fast-paced environment.
  • Willingness and ability to travel as required, up to 35% of the time. Expected to travel to support investigator meetings and site initiation visits and support monitoring where needed.

Recruiting Agencies: We do not accept unsolicited resumes from third parties for any of our open positions. To submit resumes for our jobs, a fully executed contract must be in place. We are not working with additional third party agencies at this time.

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