Key Responsibilities and Required Skills for Cardiac Clinical Research Manager

🎯 Role Definition

The Cardiac Clinical Research Manager leads the day-to-day operational management of investigator-initiated and industry-sponsored cardiovascular clinical trials. This role is accountable for program delivery — ensuring studies meet timelines, enrollment goals, quality standards and regulatory requirements — while mentoring site staff and coordinating cross-functional stakeholders (PI, clinical operations, safety, data management, biostatistics, finance, and external vendors/CROs). The ideal candidate combines hands-on cardiac trial experience with strong leadership, budget stewardship, and a demonstrated ability to optimize recruitment and site performance across multi-center studies.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator (CRC) with cardiovascular trial experience
Clinical Research Associate (CRA) or Senior CRA who has monitored cardiac studies
Registered Nurse (RN) or Physician Assistant with research management or trial coordination experience

Advancement To:

Director of Clinical Research (Cardiology)
Senior Program Manager / Head of Clinical Operations (Cardiovascular)
VP of Clinical Development / Global Clinical Operations

Lateral Moves:

Clinical Project Manager (therapeutic area lead)
Regulatory Affairs Manager (clinical/regulatory interface)
Clinical Quality Assurance / Audit Lead

Core Responsibilities

Primary Functions

Lead operational planning and execution for multiple concurrent cardiac clinical trials, ensuring adherence to protocol, study timelines, and enrollment targets across all sites and regions.
Oversee study start-up activities including feasibility assessments, site selection, investigator meetings, IRB/EC submissions, contracts, and budgeting to accelerate timelines and reduce time-to-first-patient-in (FPI).
Develop, maintain and implement study-specific project plans, milestones and risk mitigation strategies; proactively identify operational bottlenecks and implement corrective actions.
Serve as primary operational liaison to Principal Investigators, site teams, CRO partners and sponsor representatives; manage expectations and align cross-functional priorities.
Supervise, mentor and evaluate site-based research coordinators, study nurses and study managers; conduct performance reviews and promote continuous professional development.
Manage study budgets, financial forecasting, billing compliance, and vendor payments; negotiate study contracts, subawards, and investigator agreements in partnership with finance and legal teams.
Ensure full compliance with ICH-GCP, FDA, EMA, and local regulatory requirements for cardiac devices and drug trials; maintain up-to-date regulatory knowledge and implement SOPs accordingly.
Lead and coordinate safety surveillance activities including adverse event (AE/SAE) collection, expedited reporting, safety signal evaluation, and Drug Safety/Device Safety coordination with pharmacovigilance teams.
Oversee data quality and integrity by coordinating with data management on eCRF design, query resolution, source data verification strategy, and database lock readiness.
Plan and conduct site initiation visits (SIVs), routine monitoring oversight, and close-out visits; implement corrective and preventive actions (CAPAs) when findings arise.
Drive recruitment and retention strategies tailored for cardiac patient populations, working with sites to optimize screening, enrollment funnels, and patient engagement programs.
Prepare, review and approve study documents including informed consent forms (ICFs), investigator brochures (IBs), protocols, amendments, and regulatory submissions.
Coordinate central and on-site monitoring activities; define monitoring plans and risk-based monitoring approaches to ensure cost effective oversight.
Manage CRO and vendor relationships (e.g., central labs, core labs, imaging vendors, device vendors); oversee vendor deliverables, timelines and quality metrics.
Facilitate cross-functional meetings (project team, safety, data review, steering committee) and provide clear, timely project status updates and escalation when needed.
Oversee investigational product/device accountability, logistics, cold chain management (if applicable), and reconciliation across sites.
Lead readiness activities for inspections and audits; prepare regulatory binders, respond to audit queries, and implement audit remediation plans.
Collaborate with biostatistics and medical writing teams on statistical analysis plans (SAPs), interim analyses, and clinical study reports (CSRs).
Maintain comprehensive documentation in CTMS and study files; ensure TMF completeness and regulatory file readiness.
Track and report study KPIs and operational metrics (enrollment, query rates, monitoring coverage, budget burn) to senior leadership and stakeholders.
Implement continuous improvement initiatives to streamline trial operations, enhance data quality, and reduce study cycle times for cardiac programs.
Provide strategic input into protocol design from an operational feasibility perspective to ensure realistic inclusion/exclusion criteria, visit schedules, and endpoints.
Support publication and presentation planning by coordinating clinical site contributions and ensuring data integrity for abstracts, posters and manuscripts.

Secondary Functions

Support ad-hoc safety, regulatory and scientific data requests from sponsors, investigators and health authority audits.
Contribute operational input for grant applications, investigator-initiated studies and clinical trial proposals in cardiology.
Act as backup CRA/monitor during resource constraints to maintain oversight and compliance at key sites.
Participate in process improvement initiatives for CTMS use, TMF quality and eTMF completeness.
Mentor junior staff on GCP, SOPs, regulatory submissions and effective site engagement strategies.
Support preparation of investigator meeting materials and ongoing site training programs.
Assist with investigator remuneration and invoice reconciliation processes.
Engage patient advocacy groups and site coordinators to optimize recruitment outreach and patient retention programs.

Required Skills & Competencies

Hard Skills (Technical)

Deep knowledge of ICH-GCP, FDA/EMA regulations, human subject protection and local regulatory requirements for cardiac trials.
Proven experience with CTMS platforms (e.g., OnCore, Veeva, Oracle CTMS) and eTMF systems.
Hands-on experience with EDC platforms (Medidata Rave, REDCap, Oracle Clinical) and query resolution workflows.
Clinical operations expertise for device and drug trials (including device IDE/approval pathways and drug IND familiarity where applicable).
Budget development, contract negotiation, investigator payment management and financial forecasting for clinical studies.
Safety reporting proficiency: AE/SAE reporting, expedited reporting, and working with pharmacovigilance teams.
Strong understanding of monitoring practices (on-site, remote and risk-based monitoring) and sponsor/CRO oversight models.
Experience coordinating cardiac-specific endpoints and assessments (ECG, echocardiography, biomarkers, angiography, functional outcomes).
Familiarity with imaging and core lab workflows, cardiac imaging standards (DICOM), and central review processes.
Proficiency in Microsoft Office (Excel, PowerPoint, Word) and experience preparing project dashboards and study status reports.
Knowledge of TMF requirements and experience maintaining inspection-ready regulatory documentation.
Basic exposure to statistical concepts, SAPs and the clinical study reporting process; experience liaising with biostatistics.
Vendor management and procurement experience, including service level agreements and performance metrics.

Soft Skills

Strong leadership and people-management skills; ability to inspire and develop multi-disciplinary teams.
Excellent interpersonal and stakeholder management; effective at building trusted relationships with PIs, CROs and sponsors.
Superior written and verbal communication skills for producing clear status reports, regulatory documents and presentations.
Detail-oriented with strong organizational skills and the ability to manage competing priorities under tight timelines.
Problem-solving mindset and proactive risk identification with pragmatic mitigation strategies.
High level of integrity and ethical judgment in handling patient data and regulatory compliance.
Adaptability and comfort with ambiguity in fast-paced clinical development environments.
Coaching and mentorship abilities to foster site and staff performance improvements.
Project management acumen and experience using agile or milestone-driven approaches.
Results-driven, accountable and focused on delivering high-quality trial outcomes.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Nursing (BSN), Life Sciences, Public Health, Healthcare Administration, or a related field.

Preferred Education:

Master's degree (MS, MPH, MSN) or advanced clinical degree (MD, PharmD) preferred.
Clinical research certification(s) preferred — e.g., SOCRA, ACRP, CCRP.

Relevant Fields of Study:

Nursing (BSN/MSN)
Clinical Research / Clinical Trials Management
Public Health (MPH)
Biological Sciences / Biomedical Engineering
Pharmacology / Physiology

Experience Requirements

Typical Experience Range: 5–10+ years in clinical research with progressive responsibility; 3+ years in a management role preferred.

Preferred:

Minimum 5 years managing clinical trials and 3+ years specifically in cardiovascular/cardiac trials (device or drug).
Demonstrated experience leading multi-center or global clinical studies, working with academic and community sites.
Prior experience managing CROs, vendors, budgets and regulatory submissions (IRB/EC, FDA, ethics).
Experience preparing for inspections and responding to regulatory queries desirable.
Proven track record of meeting enrollment targets and improving site performance in cardiac populations.

Keywords: Cardiac Clinical Research Manager, cardiovascular clinical trials, GCP, ICH, FDA, IRB submissions, CRO management, CTMS, EDC, device trials, clinical operations, site management, safety reporting, protocol development, investigator relations, budget management, enrollment strategies, monitoring, TMF, eTMF, cardiac imaging, echocardiography.