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Clinical Operations Contractor

  • Clinical Operations Contractor job type Posted on: Oct 28, 2026
  • Clinical Operations Contractor experience level Rishabh RPO
  • Clinical Operations Contractor employment type Berkeley Heights, New Jersey
  • Clinical Operations Contractor employment type Onsite
  • Clinical Operations Contractor salary Full-time
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Job Title :

Clinical Operations Contractor

Job Type :

Full-Time

Job Location :

Berkeley Heights New Jersey United States

Remote :

No

Jobcon Logo Job Description :

Title: Clinical Operations Contractor
Job Location: Berkeley Heights, NJ
Job Type: Contract | Hybrid-1 day onsite weekly
Industry: Biopharmaceutical / Rare Disease
The Challenge
Our client, a global biopharmaceutical organization dedicated to developing innovative therapies for patients with rare diseases, is seeking an experienced Clinical Operations Contractor to lead the planning, execution, and management of clinical trials.
This is a hands-on opportunity for a Clinical Operations professional with extensive experience managing clinical studies from protocol development and study startup through execution, data review, regulatory submissions, and study closeout.
The ideal candidate will bring strong expertise in clinical trial operations, CRO and investigator site management, protocol development, study budgets, and regulatory compliance, along with the ability to collaborate effectively with cross-functional clinical development teams.
Roles & Responsibilities
Clinical Trial Management & Execution
Lead clinical trial planning, execution, oversight, and closeout across one or more therapeutic indications.
Manage clinical study timelines, milestones, deliverables, and operational activities throughout the study lifecycle.
Contribute to clinical trial design, protocol development, Case Report Form (CRF) design, and clinical study plans.
Oversee site selection, study startup, patient enrollment, investigational drug forecasting, monitoring activities, and study reporting.
Evaluate clinical data to identify potential safety, efficacy, enrollment, and data-quality trends.
Develop strategies to support successful trial execution, patient safety, and data integrity.
CRO, Vendor & Investigator Site Management
Manage relationships with Clinical Research Organizations (CROs), investigative sites, vendors, and external clinical partners.
Participate in site feasibility assessments, selection, qualification, and approval.
Negotiate and oversee clinical trial contracts, site budgets, and vendor agreements.
Plan and coordinate investigator meetings, including preparing and delivering presentations.
Address and resolve operational issues raised by investigators, clinical sites, and study monitors.
Monitor vendor performance and ensure adherence to study timelines, budgets, and quality expectations.
Clinical Documentation & Regulatory Support
Develop, review, and edit clinical study protocols, protocol amendments, informed consent forms, study manuals, and related documentation.
Collaborate with scientific and clinical teams to evaluate clinical literature and incorporate findings into study strategies.
Support regulatory submissions, including preparation of clinical documentation for regulatory agencies, Institutional Review Boards (IRBs), and Ethics Committees (ECs).
Contribute to clinical study reports, regulatory submissions, scientific publications, and conference materials.
Ensure clinical trial activities comply with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), ICH guidelines, and applicable regulatory requirements.
Project Management & Cross-Functional Collaboration
Develop and manage clinical study budgets, timelines, resource plans, and project deliverables.
Track study expenditures, vendor costs, and investigational site budgets.
Provide regular clinical study progress reports to internal leadership and cross-functional teams.
Partner with Clinical Development, Clinical Data Management, Regulatory Affairs, Medical, and external research organizations.
Identify operational risks, resolve study challenges, and implement strategies to improve clinical trial execution.
Maintain accurate clinical documentation and ensure compliance with company Standard Operating Procedures (SOPs).
Required Qualifications
Bachelor's degree in a scientific discipline.
7+ years of progressively responsible clinical research experience within a pharmaceutical, biotechnology, CRO, academic medical center, or related environment.
Demonstrated experience managing US and/or global clinical trials across the study lifecycle.
Strong knowledge of clinical trial design, protocol development, study execution, data collection, and clinical study reporting.
Experience managing CROs, investigator sites, external vendors, and clinical trial budgets.
Hands-on experience supporting clinical study startup, enrollment, monitoring, data review, and closeout activities.
Comprehensive understanding of the drug development process and clinical research operations.
Working knowledge of GCP, GMP, ICH guidelines, and applicable regulatory requirements.
Ability to identify and evaluate clinical data trends related to safety, efficacy, and study performance.
Strong project management, organizational, communication, and problem-solving skills.
Ability to independently manage multiple clinical studies and collaborate across cross-functional teams.
Proficiency with Microsoft Word and Excel.
Preferred Qualifications
Previous involvement in Investigational New Drug (IND) and New Drug Application (NDA) submissions.
Prior experience as a Clinical Research Associate (CRA) or field monitor.
Medical writing experience, including clinical protocols, study reports, and regulatory documentation.
Experience managing global or complex clinical development programs.
Proficiency with Microsoft Project and PowerPoint.
Experience supporting clinical development programs within pharmaceutical or biotechnology organizations.

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Jobcon Logo Position Details

Posted:

Oct 28, 2026

Reference Number:

31380-1120

Employment:

Full-time

City:

Berkeley Heights

Job Origin:

CIEPAL_ORGANIC_FEED

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Title: Clinical Operations Contractor
Job Location: Berkeley Heights, NJ
Job Type: Contract | Hybrid-1 day onsite weekly
Industry: Biopharmaceutical / Rare Disease
The Challenge
Our client, a global biopharmaceutical organization dedicated to developing innovative therapies for patients with rare diseases, is seeking an experienced Clinical Operations Contractor to lead the planning, execution, and management of clinical trials.
This is a hands-on opportunity for a Clinical Operations professional with extensive experience managing clinical studies from protocol development and study startup through execution, data review, regulatory submissions, and study closeout.
The ideal candidate will bring strong expertise in clinical trial operations, CRO and investigator site management, protocol development, study budgets, and regulatory compliance, along with the ability to collaborate effectively with cross-functional clinical development teams.
Roles & Responsibilities
Clinical Trial Management & Execution
Lead clinical trial planning, execution, oversight, and closeout across one or more therapeutic indications.
Manage clinical study timelines, milestones, deliverables, and operational activities throughout the study lifecycle.
Contribute to clinical trial design, protocol development, Case Report Form (CRF) design, and clinical study plans.
Oversee site selection, study startup, patient enrollment, investigational drug forecasting, monitoring activities, and study reporting.
Evaluate clinical data to identify potential safety, efficacy, enrollment, and data-quality trends.
Develop strategies to support successful trial execution, patient safety, and data integrity.
CRO, Vendor & Investigator Site Management
Manage relationships with Clinical Research Organizations (CROs), investigative sites, vendors, and external clinical partners.
Participate in site feasibility assessments, selection, qualification, and approval.
Negotiate and oversee clinical trial contracts, site budgets, and vendor agreements.
Plan and coordinate investigator meetings, including preparing and delivering presentations.
Address and resolve operational issues raised by investigators, clinical sites, and study monitors.
Monitor vendor performance and ensure adherence to study timelines, budgets, and quality expectations.
Clinical Documentation & Regulatory Support
Develop, review, and edit clinical study protocols, protocol amendments, informed consent forms, study manuals, and related documentation.
Collaborate with scientific and clinical teams to evaluate clinical literature and incorporate findings into study strategies.
Support regulatory submissions, including preparation of clinical documentation for regulatory agencies, Institutional Review Boards (IRBs), and Ethics Committees (ECs).
Contribute to clinical study reports, regulatory submissions, scientific publications, and conference materials.
Ensure clinical trial activities comply with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), ICH guidelines, and applicable regulatory requirements.
Project Management & Cross-Functional Collaboration
Develop and manage clinical study budgets, timelines, resource plans, and project deliverables.
Track study expenditures, vendor costs, and investigational site budgets.
Provide regular clinical study progress reports to internal leadership and cross-functional teams.
Partner with Clinical Development, Clinical Data Management, Regulatory Affairs, Medical, and external research organizations.
Identify operational risks, resolve study challenges, and implement strategies to improve clinical trial execution.
Maintain accurate clinical documentation and ensure compliance with company Standard Operating Procedures (SOPs).
Required Qualifications
Bachelor's degree in a scientific discipline.
7+ years of progressively responsible clinical research experience within a pharmaceutical, biotechnology, CRO, academic medical center, or related environment.
Demonstrated experience managing US and/or global clinical trials across the study lifecycle.
Strong knowledge of clinical trial design, protocol development, study execution, data collection, and clinical study reporting.
Experience managing CROs, investigator sites, external vendors, and clinical trial budgets.
Hands-on experience supporting clinical study startup, enrollment, monitoring, data review, and closeout activities.
Comprehensive understanding of the drug development process and clinical research operations.
Working knowledge of GCP, GMP, ICH guidelines, and applicable regulatory requirements.
Ability to identify and evaluate clinical data trends related to safety, efficacy, and study performance.
Strong project management, organizational, communication, and problem-solving skills.
Ability to independently manage multiple clinical studies and collaborate across cross-functional teams.
Proficiency with Microsoft Word and Excel.
Preferred Qualifications
Previous involvement in Investigational New Drug (IND) and New Drug Application (NDA) submissions.
Prior experience as a Clinical Research Associate (CRA) or field monitor.
Medical writing experience, including clinical protocols, study reports, and regulatory documentation.
Experience managing global or complex clinical development programs.
Proficiency with Microsoft Project and PowerPoint.
Experience supporting clinical development programs within pharmaceutical or biotechnology organizations.

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