Precision Medicine Operations Lead- FSP

5 days ago

Nagpur, India Parexel Full time

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

Works with Precision Medicine Strategy Lead as well as clinical study teams to ensure quality samples and data are delivered to support biomarker evaluation and delivery of science to medicine. Responsibilities include oversight of clinical sample collection, usage per informed consent form, sample tracking (chain of custody) and sample destruction. Individual will work closely with internal and external groups/vendors to manage and support the generation of quality biomarker data. Will work closely with clinical sites and project managers (central and/or specialty laboratories) to ensure samples are collected per protocol and to resolve any sample related issues or queries. Additional responsibilities include overall project/portfolio management and alignment amongst studies.

Key Accountabilities :

Accountability

Supporting Activities

Compliance with Parexel standards

Comply with timely completion of required training curriculum Complete timesheets accurately as required (weekly) Submit expense reports as required (within 30 days) Update CV as required Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements

Study Team Support

Participates in cross-functional study teams and sub-teams across clinical and research sides of the company Works with clinical study team on the development of the ICF, including escalations from IRBs/ECs Manages acquisition of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc)

Operational Support of Biomarker and Exploratory Analysis

Establishment, oversight, planning, and integration of all issues related to bio sample processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations Liaises with Precision Medicine Strategy Leads by assessing vendors, forecasting the biomarker sample operational costs, timelines and reviewing invoices to ensure we are aligned with budget plans

Data Acquisition and Management

Works closely with data management lead to determine how biomarker data will be captured, blinded and transferred for clinical trials. Enables transfer of biomarker/exploratory data from vendor through development and review of an appropriate data transfer specification and related documents

Human Sample Management Flow and Compliance

Provides guidance to clinical teams and clinical sites regarding collection and storage of biospecimen acquired in the course of clinical trials or other human sample acquisition projects Works with Precision Medicine Strategy Leads and clinical team to ensure sample collection and usage is in compliance Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed

Skills:

Excellent written and verbal communication skills Analytical problem-solving experience Problem solving abilities, troubleshooting and resourcefulness Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable Effective communication and interpersonal skills The ability to build relationships internally and externally Familiarity with medical terms Demonstrates writing skills to deliver messages effectively so messages are clearly understood Proficiency in Microsoft Office applications

Knowledge and Experience :

6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. We are seeking a working knowledge of the clinical trials and clinical databases.

Education:

BS degree required – Major/ Minor (Biology or equivalent)

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.

  • Senior Precision Medicine Associate

    5 days ago

    nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Key Accountabilities:Accountability, Supporting ActivitiesMay include but not limited to the followingStudy Team Support• Collaborates within cross functional study teams• Presents at investigator meetings and creates training materials (lab manual, sample collection procedures and...

  • Senior Precision Medicine Associate

    4 days ago

    Nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Key Accountabilities: Accountability, Supporting Activities May include but not limited to the following Study Team Support • Collaborates within cross functional study teams • Presents at investigator meetings and creates training materials (lab manual, sample collection procedures...

  • Clinical Trial Oversight Lead

    2 days ago

    Nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.Parexel is seeking a Clinical Trial Oversight lead in the Northeast US or in Florida!Position Purpose:The Clinical Trial Oversight Lead (CTOL) is responsible for the following:Oversight of outsourced monitoring activities to ensure adherence to the protocol, Good ClinicalPractice (GCP), evolving...

  • Early Clinical Scientist- Translational Medicine

    4 weeks ago

    Nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Parexel FSP has an exciting opportunity for a Clinical Scientist! The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials with the Clinical Director, and internal/external team members. Oversees trials within and/or across...

  • Early Clinical Scientist- Translational Medicine

    4 weeks ago

    Nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Parexel FSP has an exciting opportunity for a Clinical Scientist! The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials with the Clinical Director, and internal/external team members. Oversees trials within and/or across...

  • Clinical Trial Oversight Lead

    4 weeks ago

    Nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Parexel is seeking a Clinical Trial Oversight lead in the Northeast US or in Florida! Position Purpose: The Clinical Trial Oversight Lead (CTOL) is responsible for the following: Oversight of outsourced monitoring activities to ensure adherence to the protocol, Good Clinical ...

  • Clinical Trial Oversight Lead

    4 weeks ago

    Nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Parexel is seeking a Clinical Trial Oversight lead in the Northeast US or in Florida! Position Purpose: The Clinical Trial Oversight Lead (CTOL) is responsible for the following: Oversight of outsourced monitoring activities to ensure adherence to the protocol, Good Clinical ...

  • Clinical Trial Oversight Lead

    4 weeks ago

    nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Parexel is seeking a Clinical Trial Oversight lead in the Northeast US or in Florida! Position Purpose: The Clinical Trial Oversight Lead (CTOL) is responsible for the following: Oversight of outsourced monitoring activities to ensure adherence to the protocol, Good Clinical ...

  • Early Clinical Scientist- Translational Medicine

    4 weeks ago

    nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Parexel FSP has an exciting opportunity for a Clinical Scientist! The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials with the Clinical Director, and internal/external team members. Oversees trials within and/or...

  • Administration Assistant

    4 days ago

    Nagpur, India Precision Bearings Full time

    Precision Bearings is a distributor of Industrial Bearings supplying to Government as well as private organizations. Your responsibilities will include but not limited to communicating with clients, government documentation and day to day office administrative work. **Responsibilities**: - Data Entry in MS Excel & Word, Tally ERP - Knowledge of E-Tendering...

  • Country Study Operations Manager

    1 week ago

    Nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.The Study Operations Manager (SOM) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on studies of limited complexity (a small number of countries/sites) or manages portions of a larger study (such as recruitment...

  • Country Study Operations Manager

    2 weeks ago

    Nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   The Study Operations Manager (SOM) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on studies of limited complexity (a small number of countries/sites) or manages portions of a larger study (such as...

  • Country Study Operations Manager

    2 weeks ago

    nagpur, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   The Study Operations Manager (SOM) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on studies of limited complexity (a small number of countries/sites) or manages portions of a larger study (such as...

  • Lathe Machine Operator

    2 weeks ago

    Nagpur, Maharashtra, India Daffodil Engravers India Pvt Ltd Full time

    Job Decripation*Job Title: Lathe Machine Operator**Summary:*The Lathe Operator is responsible for setting up, operating, and maintaining lathe machines to fabricate, modify, or repair parts and components made from various materials. This role requires precision, attention to detail, and adherence to safety protocols.*Key Responsibilities:**Machine Setup:*...

  • Administration Assistant

    2 weeks ago

    Nagpur, Maharashtra, India Precision Bearings Full time

    Precision Bearings is an Industrial Bearings distributor supplying to Government as well as private organizations. Your responsibilities will include but not limited to communicating with clients, government documentation and day to day office administrative work. **Responsibilities**: **Qualifications**: - Associate's degree in Business Administration,...

  • Administration Assistant

    3 weeks ago

    Nagpur, Maharashtra, India Precision Bearings Full time

    Precision Bearings is an Industrial Bearings distributor supplying to Government as well as private organizations. Your responsibilities will include but not limited to communicating with clients, government documentation and day to day office administrative work. **Responsibilities**: **Qualifications**: - Associate's degree in Business Administration,...

  • Maintenance Supervisor

    4 weeks ago

    Nagpur, India SKG Refractories Ltd Full time

    **Duties/ Responsibilities**: - Performs maintenance management by supervising maintenance personnel and establishing priorities in maintenance schedules. - To attend day to day issues of ESP, FSP, Hydraulic Presses in Shifts incl. Mould related issues and quick handing over of Press to Production Deptt. - Knowledge on Pressing Operation, Mechanism, Dies...

  • Lathe Machine Operator

    2 weeks ago

    Nagpur, Maharashtra, India Daffodil Engravers(India) Pvt Ltd Full time

    **Job Decripation** *Job Title: Lathe Machine Operator* *Summary:* The Lathe Operator is responsible for setting up, operating, and maintaining lathe machines to fabricate, modify, or repair parts and components made from various materials. This role requires precision, attention to detail, and adherence to safety protocols. *Key Responsibilities:* -...

  • Cmm Operator

    2 weeks ago

    Nagpur, India Meraqui Ventures Pvt Ltd Full time

    **CMM Operator (Coordinate Measuring Machine Operator)**: A CMM operator is a person who operates a Coordinate Measuring Machine. CMM is a precision measurement device used in manufacturing and quality control processes to measure the physical geometrical characteristics of an object. The operator would be responsible for setting up the CMM, programming it...

  • Machine Operator

    4 weeks ago

    Nagpur, India ANSHIKA FASTENERS PRIVATE LIMITED Full time

    Anshika is a leading manufacturer in the fasteners industry, dedicated to delivering high-quality products to our clients worldwide. We pride ourselves on innovation, precision, and a commitment to excellence in our manufacturing processes. **Responsibilities**: - Operate and monitor machinery used in the production of fasteners. - Perform routine...