Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

Clinical Trial Management Systems Biomedical Instrumentation Data Management Adverse Event Monitoring Site Reliability Engineering Data Privacy Laws Clinical Study Design Compliance Management Pharmaceutical Product Management Auditing Query Planning Process Optimization Change Management Cultural Studies Business Negotiation

Other Skills

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Quality Control
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Analytical Skills
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Multitasking
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Virtual Collaboration
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Non-Verbal Communication
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Adaptability
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Teamwork
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Detail Oriented
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Social Skills

Roles & Responsibilities

Bachelor's degree in life sciences or related discipline (or equivalent).
Excellent knowledge of ICH-GCP; basic knowledge of GMP/GDP; good knowledge of local regulations.
Good understanding of clinical study management including monitoring, study drug handling, and data management.
Excellent written and verbal communication skills; fluency in English; local language proficiency; ability to travel nationally/internationally.

Requirements:

Contribute to investigator selection and oversee study start-up/regulatory maintenance, including site qualification visits and submission of documents to EC/IRB and regulators.
Train, support, and advise investigators and site staff on trial-related matters, ensuring training compliance (e.g., ICH-GCP) and site readiness; participate in Local Study Team and National Investigators meetings.
Perform monitoring visits (onsite and remote) and remote data checks; conduct SDR/CRF/SDV per Monitoring Plan; ensure timely data query resolution and escalation of issues.
Maintain study documentation and regulatory readiness: manage ISF and drug supplies, update CTMS/eTMF, support audits/inspections, and ensure timely reporting of SAEs.

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

Site Management Responsibilities

Contributes to the selection of potential investigators.

In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulator Authorities for start-up and for the duration of the study.

Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.

Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.

Actively participates in Local Study Team (LST) meetings.

Contributes to National Investigators meetings, as applicable.

Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.

Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.

Updates CTMS and other systems with data from study sites as per required timelines.

Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.

Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits.

Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.

Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.

Ensures data query resolution in a timely manner.

Works with data management to ensure robust quality of the collected study data.

Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.

Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.

Follows up on outstanding actions with study sites to ensure resolution in a timely manner.

Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.

Assists site in maintaining inspection ready ISF.

Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).

Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.

Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.

Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.

Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.

Compliance with Sponsor Standards

Ensures compliance with the Client’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).

Ensures compliance with local, national, and regional legislation, as applicable.

Completes timesheets accurately as required.

Compliance with Parexel Standards

Complies with required training curriculum.

Completes timesheets accurately as required.

Submits expense reports as required.

Updates CV as required.

Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.

Skills (Essential):

Excellent attention to detail.

Good written and verbal communication skills.

Good collaboration and interpersonal skills.

Good negotiation skills.

Proficient in written and spoken English language required.

Fluency in local language(s) required.

Skills (Desirable):

Ability to work in an environment of remote collaborators.

Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.

Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

Good analytical and problem-solving skills.

Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.

Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

Knowledge and Experience (Essential):

Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. • Good knowledge of relevant local regulations.

Good medical knowledge and ability to learn relevant Client Therapeutic Areas.

Basic understanding of the drug development process.

Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

Knowledge and Experience (Desired):

Familiar with risk-based monitoring approach including remote monitoring.

Good cultural awareness.

Education:

Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.

Other: