Source Job

  • Serve as Medical Monitor for assigned clinical trials, reviewing emerging medical/safety data and collaborating with CRO partners.
  • Play an active role in planning, conduct, and evaluation of ongoing clinical trials to ensure successful execution.
  • Contribute to authoring and critical review of regulatory documents and scientific data disclosures.

Clinical Trials GCP Regulatory Submissions

18 jobs similar to Director - Clinical Development (Medical Monitoring)

Jobs ranked by similarity.

Spain

  • Serve as medical point of contact for internal project teams, study sites, and sponsors on medical matters related to clinical trials.
  • Review and analyze clinical data to ensure participant safety and ensure trial data accuracy and compliance with protocols.
  • Collaborate with departments to prepare clinical development plans, protocols, and scientific presentations, and lead advisory boards.

PSI is a leading Contract Research Organization with 30 years of experience in the pharmaceutical industry, supporting clinical trials globally. As a privately owned, full-service CRO, we foster an inclusive culture where a diverse range of colleagues feel welcomed and valued, enabling us to attract and retain top talent.

US

  • Oversee clinical site management and ensure compliance with protocols, regulations, and quality standards.
  • Serve as primary contact for study sites, conducting monitoring visits from pre-study through close-out.
  • Collaborate with cross-functional teams to support data review, regulatory submissions, and site performance.

Our partner is a global clinical research organization managing monitoring activities across Phase I–IV trials and Real World Evidence studies. It offers a collaborative, fully remote environment focused on improving patient outcomes with professional growth opportunities.

  • Conduct on-site or remote monitoring visits including Pre-Study, Initiation, Interim, and Close-Out activities to ensure site adequacy and compliance.
  • Verify investigator qualifications, resources, and facilities, and train investigational site staff as necessary.
  • Support regulatory submissions and mentor junior staff through co-monitoring visits and training.

Ergomed Group is a clinical research organization (CRO) that helps biopharmaceutical companies develop, deliver, and safeguard therapies in oncology, rare disease, and other complex areas. The company fosters a culture of kindness, curiosity, and a shared sense of purpose, with a diverse team of experts in clinical research, pharmacovigilance, and quality consulting.

$175,000–$190,000/yr
US

  • Serve as the Clinical Scientist for one or more Phase 2/3 studies, contributing to study design, protocol development, and oversight.
  • Lead data review and medical monitoring activities, identifying trends, deviations, and safety signals in collaboration with Medical Monitors.
  • Support regulatory submissions, cross-functional partnerships, and scientific publications to advance clinical development.

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a growing company with a collaborative, fast-paced environment where individual contributions have significant impact.

Germany

  • Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
  • Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
  • Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.

Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.

US

  • Oversee critical monitoring activities across clinical trials, ensuring compliance with protocols and regulations.
  • Collaborate with investigators and site teams to maintain study integrity and operational excellence.
  • Support Phase II and Phase III trials in challenging therapeutic areas to improve patient outcomes.

Jobgether uses artificial intelligence to match job seekers with opportunities through a fair and efficient process. As a growing platform, they emphasize collaboration, integrity, and patient impact in their culture.

US 3w PTO

  • Serve as the site manager, ensuring data entry and query resolution, and maintain high-quality data and audit readiness at clinical sites.
  • Monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting, both onsite and remotely.
  • Manage device accountability, inventory, distribution, and regulatory documentation to ensure compliance and audit readiness.

Penumbra is a global healthcare company focused on innovative therapies, designing, developing, manufacturing, and marketing novel products for challenging medical conditions. The company sells its products to hospitals and healthcare providers worldwide through direct sales and distributors.

$142,400–$224,100/yr
US

  • Manage a team of 6-14 CRAs to ensure excellent study and site performance with strict adherence to local regulations, company SOPs, and ICH GCP.
  • Provide training, support, and mentoring to CRAs, manage low or non-performance situations, and contribute to capacity planning.
  • Collaborate with local stakeholders, including CRMs and PLMs, to ensure alignment across monitoring functions and resolve site or CRA operational issues.

We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare, supported by a large and diverse workforce.

US

  • Oversee day-to-day operations of clinical trials, ensuring compliance with GCP, FDA, and ICH guidelines while managing CROs and vendors.
  • Serve as primary point of contact for CROs and trial vendors, tracking performance metrics, budgets, and timelines to ensure project success.
  • Collaborate with cross-functional teams to prioritize data integrity, participant safety, and quality control, with travel required up to 30%.

Peptilogics is a surgical therapeutics company dedicated to curing and preventing medical device-related infections. They are a clinical-stage biotech with a small, agile team and a culture of proactive, independent thinking.

US

  • Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
  • Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards.
  • Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. As a small, mission-driven team, we foster a collaborative culture built on trust, ownership, curiosity, and results.

France

  • You will monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted per protocol, SOPs, ICH-GCP, and regulations.
  • You will coordinate all necessary activities to set up and monitor a study, including identifying investigators and preparing regulatory submissions.
  • You will identify potential study risks and propose solutions to mitigate them, demonstrating an impeccable eye for detail.

Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease, and are proud to share extremely high CRA retention rates compared to industry averages.

US

  • Provide strategic and operational leadership for Immunome's clinical trial monitoring function, including implementing contract field monitoring team and standardizing monitoring strategy across the oncology portfolio.
  • Lead and develop a high-performing field monitoring function, partnering closely with Clinical Site and Trial Operations, Data Management, and Quality to ensure data quality and patient safety.
  • Manage monitoring budgets, resources, and vendor oversight, ensuring compliance with ICH-GCP, FDA, EMA regulations and driving inspection readiness.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. They have a leadership team experienced in design, development, and commercialization of cutting-edge therapies including antibody-drug conjugates.

$215,000–$240,000/yr
US

  • Oversee strategic and operational execution of clinical trials, leading cross-functional teams and managing vendor selection.
  • Direct clinical trial budgets, risk mitigation, and provide technical input into key clinical documents.
  • Mentor staff and foster strong team relationships in a dynamic organization.

Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. The company was launched based on assets licensed from Paragon Therapeutics and has a growing pipeline.

$145,000–$165,000/yr
US Unlimited PTO

  • Provide scientific and medical direction to integrate clinical relevance into client brand strategies.
  • Monitor disease categories and product labeling to derive actionable insights for medical strategy.
  • Support senior Medical staff in new business and thought leadership while training junior team members.

Inizio Evoke is a healthcare communications agency that aims to make health more human through strategic and creative work. They foster an inclusive, authentic culture and offer flexible work environments with a focus on collaboration and professional growth.

US

  • Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
  • Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
  • Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.

Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.

US

  • Manage and monitor soft tissue ablation clinical trials, including site start-up, patient recruitment, and data quality.
  • Prepare study documents, oversee monitoring visits, and ensure compliance with FDA and ICH-GCP regulations.
  • Mentor other CRAs and support both U.S.-based and future international clinical studies.

Pulse Biosciences is a novel bioelectric medicine company developing the CellFX nsPFA technology for non-thermal ablation. The company is publicly traded (Nasdaq: PLSE), fosters a culture of innovation and collaboration, and is committed to hiring top talent.

US

  • Conduct remote and onsite monitoring activities including Site Initiation, Interim, and Closeout Visits.
  • Review informed consent, source documentation, and case report forms for accuracy and completeness.
  • Identify, document, and escalate protocol deviations, data quality concerns, and compliance risks.

WHOOP is on a mission to unlock human performance and healthspan, empowering members to perform at a higher level through a deeper understanding of their bodies and daily lives. They are a leading wearable technology company with a collaborative and detail-oriented culture.

Europe

  • Perform on-site or remote monitoring visits to ensure site adequacy for clinical studies.
  • Verify investigator qualifications and support regulatory submissions.
  • Train site staff and ensure compliance throughout the study period.

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. They have a collaborative, international team with colleagues across the globe, valuing teamwork, flexibility, and work-life balance.