Medical Operations Leader

Parexel; Denver (CO); Remote; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Parexel is seeking a Senior Clinical Scientist to lead or support complex studies, ensuring clinical/scientific execution of protocols. You will act as the clinical point of contact for scientific issues for internal and external stakeholders, and oversee Medical Monitoring activities including the development of the Medical Monitoring Plan and SAE review.

You will collaborate in study design, endpoint development, and regulatory/compliance activities, coordinating with medical writing and

Qualifikationen

• Minimum 7 years in pharmaceutical/clinical drug development within last 10 years with BS/BA; 5 years with MS/PhD.
• Minimum 2 years as a lead Clinical Scientist on phase I-IV studies.
• 2+ years in medical monitoring and data review for safety and efficacy.
• Oncology TA experience preferred (IDV and GSM).
• Degree in Life Sciences; BS/BA or higher.

Aufgaben

• Lead or support studies; oversee clinical/scientific execution of protocols.
• Serve as clinical point of contact for scientific issues with internal and external stakeholders.
• Lead Medical Monitoring activities, develop MMP, review SAE reports.
• Contribute to study documents, governance reviews, and CSR/WMAs planning.
• Coordinate lab, bio specimens and imaging specifications; support publications.

Kenntnisse

Data review

Oral & written comms

Team leadership

MS Office

Flexibility & delegation

Ausbildung

BS/BA Life Sciences

MS/PhD Life Sciences

Tools

Microsoft Office

OneNote

Jobbeschreibung

Job Overview

The Senior Clinical Scientist (SCS) may lead or support a study or studies, depending on size/complexity. The SCS as lead is accountable for the clinical/scientific execution of the protocol.

Key Accountabilities:

Oversight/Leadership

• May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol.

• As lead, will be responsible as the Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)

• Responsible for trial design and endpoint development in collaboration with CD

• Scientific lead on Clinical Trial Team (CTT)

Medical Monitoring

• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports

• Monitors data issues requiring clinical input

• Monitors central lab reports and other external data for safety and critical values

• Prepares scientific slides, attends and presents protocol information at Investigator Meeting

• Participates in Database lock activities

• Reconciles and review all protocol deviation classifications in SPECTRUM

Clinical Trial Operational Delivery

• Sets up/supports SAC, DMC, adjudication committees

• Protocols/amendments – collaborates with medical writer, participates in governance committee review

• Authors protocol clarification letters

• Contributor to study specific documents (e.g., SMP)

• Reviews/updates informed consent

• Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)

• Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system

• Coordinates planning of lab, bio specimens and imaging specifications

• Co-authors newsletters with SM

• Collaboratively plans CSRs, CTDs/WMAs with medical writing

• Supports publications/presentations as needed

• Assesses and prepares protocol deviation list for CSR

• Collaborates with medical writing to develop trial results communication for investigators

• Provides scientific assessment for Operational Reviews

• Supports SM/MW activities as needed to achieve CTT deliverables.

• Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)

• May act as mentor to other CSs

Compliance with Parexel Standards

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Experience reviewing and resolving study related data issues such as issued queries, resolved queries, accurate review of medical records, identify any errors in data by performing data review that require further clarification with the study sites, etc. required

• Demonstrated oral and written communication skills

• Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required. One Note experience preferred.

• Motivate their team, handle and delegate responsibilities, listen to feedback and remain flexible .

Knowledge and Experience :

• Minimum 7 years with BS/BA or 5 years with MS/PhD pharmaceutical and/or clinical drug development (such as pharmaceutical/biopharma companies, hospital settings, research sites, clinical trial units, CRO, SMO) in the last 10 years required experience

• Minimum 2 years as a lead CS (phase I-IV clinical trials) with pharmaceutical / biotech / CRO company experience required (leads, monitors and supervises the tasks related to clinical trials) in the last 5 years.

• Minimum 2 years medical monitoring (proficient in reviewing patient data and resolving discrepancies in the following areas such as adverse events, trends of adverse events, end point management, labs) experience required

• TA-specific experience required for Oncology. TA specific experience preferred for IDV and GSM

• Indication specific experience preferred

Education:

• Degree in Life Sciences

• Bachelor of Science/Bachelor of Arts/Master of Science/PhD

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.