Role Summary
We are seeking a highly organized and proactive Clinical Operations professional to support the successful execution of our clinical this key role you will partner closely with the Clinical Operations Study Lead to manage critical components of study deliveryensuring timelines quality standards and budget expectations are met. You will drive meeting coordination site and vendor support documentation management and quality oversight across assigned studies. This position offers the opportunity to make a meaningful impact on study execution while working with minimal oversight.
Key Responsibilities
Study Team & Meeting Management (50%)
- Lead preparation of agendas and meeting minutes for cross-functional study team meetings
- Support site start-up activities
- Manage ancillary vendors as assigned
- Participate in Investigator Meetings including presenting materials when appropriate
Study Documentation Tracking & Quality (50%)
- Monitor systems processes and vendors to ensure clinical trial data quality; identify risks and recommend improvements
- Review clinical protocols for operational feasibility and anticipate potential study delivery challenges
- Draft and maintain clinical project timelines; proactively escalate risks to the Study Lead
- Support clinical trial budget analysis and cost tracking
- Track 1572s and collaborate with Regulatory for IND submissions and essential documents
- Maintain and QC Trial Master File (TMF) documents
- Assist with creation and distribution of ICF templates manuals and other study materials
- Contribute to the review of core study documents (protocol IB CSR)
- Manage sample accountability and tracking
- Develop maintain and QC study documentation and trackers
- Perform additional operational activities as assigned
Qualifications :
Required Qualifications
- Bachelors or Masters degree with 3 years of clinical operations experience in pharma or CRO
- Strong understanding of ICH GCP and global regulatory expectations
- Ability to interpret and communicate protocol requirements
- Demonstrated experience managing components of clinical trials independently
Preferred Capabilities
- Advanced proficiency with clinical trial software platforms vendor systems and related tools
- Understanding of data-technology interdependencies vendor metrics and operational nuances across vendor types
- Excellent verbal written and presentation skills
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $116800 - $160600. Actual compensation packages will depend on various factors including but not limited to depth of experience education skillset overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Decipheras competitive total rewards strategy that also includes annual performance bonus a long-term incentive plan full range of benefits and other incentive compensation plans (if applicable)
Benefits:
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical dental vision insurance 401(k) retirement plan with company match and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
Remote Work :
No
Employment Type :
Full-time
Role SummaryWe are seeking a highly organized and proactive Clinical Operations professional to support the successful execution of our clinical this key role you will partner closely with the Clinical Operations Study Lead to manage critical components of study deliveryensuring timelines quality s...
Role Summary
We are seeking a highly organized and proactive Clinical Operations professional to support the successful execution of our clinical this key role you will partner closely with the Clinical Operations Study Lead to manage critical components of study deliveryensuring timelines quality standards and budget expectations are met. You will drive meeting coordination site and vendor support documentation management and quality oversight across assigned studies. This position offers the opportunity to make a meaningful impact on study execution while working with minimal oversight.
Key Responsibilities
Study Team & Meeting Management (50%)
- Lead preparation of agendas and meeting minutes for cross-functional study team meetings
- Support site start-up activities
- Manage ancillary vendors as assigned
- Participate in Investigator Meetings including presenting materials when appropriate
Study Documentation Tracking & Quality (50%)
- Monitor systems processes and vendors to ensure clinical trial data quality; identify risks and recommend improvements
- Review clinical protocols for operational feasibility and anticipate potential study delivery challenges
- Draft and maintain clinical project timelines; proactively escalate risks to the Study Lead
- Support clinical trial budget analysis and cost tracking
- Track 1572s and collaborate with Regulatory for IND submissions and essential documents
- Maintain and QC Trial Master File (TMF) documents
- Assist with creation and distribution of ICF templates manuals and other study materials
- Contribute to the review of core study documents (protocol IB CSR)
- Manage sample accountability and tracking
- Develop maintain and QC study documentation and trackers
- Perform additional operational activities as assigned
Qualifications :
Required Qualifications
- Bachelors or Masters degree with 3 years of clinical operations experience in pharma or CRO
- Strong understanding of ICH GCP and global regulatory expectations
- Ability to interpret and communicate protocol requirements
- Demonstrated experience managing components of clinical trials independently
Preferred Capabilities
- Advanced proficiency with clinical trial software platforms vendor systems and related tools
- Understanding of data-technology interdependencies vendor metrics and operational nuances across vendor types
- Excellent verbal written and presentation skills
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $116800 - $160600. Actual compensation packages will depend on various factors including but not limited to depth of experience education skillset overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Decipheras competitive total rewards strategy that also includes annual performance bonus a long-term incentive plan full range of benefits and other incentive compensation plans (if applicable)
Benefits:
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical dental vision insurance 401(k) retirement plan with company match and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
Remote Work :
No
Employment Type :
Full-time
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