ExecuPharm FSP - Senior Clinical Scientist

Parexel International Corporation

USA - Any Region - Home Based

About ExecuPharm

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Position Purpose:

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.

Organizational Relationships:

• Reports to ExecuPharm (EP) assigned Line Manager with day-to-day direction from Client

• Liaises with cross-functional lines as appropriate

Primary Duties:

• Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., Institutional Review Board (IRB), sites)

• Responsible for trial design and endpoint development in collaboration with Clinical Director (CD)

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

• Sets up/supports SAC (Scientific Advisory Committee), DMC (Data Monitoring Committee), adjudication committees

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

• Authors protocol clarification letters

• Contributor to study specific documents [e.g., Study Monitoring Plan (SMP)]

• Reviews/updates informed consent

• Provides scientific input to Study Manager (SM) for data management activities (e.g., Electronic Data Capture, Data Review Plan, Case Report Forms)

• 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

• Scientific lead on Clinical Trial Team (CTT)

• 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

• Participates in Database lock activities

• Collaboratively plans CSRs (Clinical Study Reports), CTDs (Common Technical Documents)/WMAs (Worldwide Marketing Authorization) with medical writing

• Supports publications/presentations as needed

• Reconciles and review all protocol deviation classifications in SMART

• 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 Study Management/Medical Writing activities as needed to achieve CTT deliverables

• Provides clinical specifications to SM to support interactions with external vendors [e.g.,Interactive Voice Response System (IVRS), electronic Patient Reported Outcome (ePRO)]

• May act as mentor to other Clinical Scientists (CSs)

• Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training

• Adhere to EP and Client SOPs and processes

QualificationsSkills and Education:

• BS/BA in Life Sciences with 7+ years clinical research experience

• MS/PhD in Life Sciences with 5+ years clinical research experience

• If no degree in Life Sciences, must have significant experience in clinical development (>11 years)

• Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required.

• Medical monitoring experience required

• Excellent Excel and PowerPoint (PP) skills required

• Excellent written and oral communication skills

• Therapeutic Area (TA) specific experience beneficialEEO DisclaimerParexel 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.

2021-05-05 00:05:49

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