Senior Clinical Scientist FSP

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

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