Role Summary:
The Senior Clinical Project Manager leads and manages complex clinical studies demonstrating advanced knowledge of clinical operations methodologies strong organizational and leadership capabilities and strategic insight. This role provides operational direction oversight and executional excellence to ensure clinical trials are delivered on time within budget and in compliance with GCP ICH and FDA regulations. The Senior Clinical Project Manager works cross-functionally to align study objectives with program goals and contributes to process improvement initiatives within a fast-paced small-to-midsize biotech environment.
Key Responsibilities:
- Clinical Trial Leadership & Oversight (40%)
- Lead the planning execution and delivery of clinical trials within specified quality time and cost parameters. Oversee CFT performance ensure operational alignment with Clinical Operations program objectives and manage multiple studies concurrently.
- Cross-Functional Team Management (25%)
- Provide leadership and guidance to cross-functional study teams (CFTs) fostering collaboration accountability and problem-solving across functions. Mentor and delegate responsibilities to support staff as appropriate.
- Vendor & CRO Oversight (15%)
- Lead interactions and negotiations with CROs and vendors to ensure adherence to contractual obligations budget and study timelines. Proactively identify and mitigate operational risks to ensure high-quality deliverables.
- Process Optimization & Strategic Execution (10%)
- Evaluate current methodologies and identify opportunities for greater efficiency and effectiveness across clinical operations processes and systems.
- Stakeholder Communication & Engagement (10%)
- Communicate study progress challenges and outcomes to internal stakeholders maintaining transparency and alignment across program leadership and clinical operations management.
- Other duties and responsibilities as assigned.
Qualifications :
Required Qualifications:
Bachelors degree in health science or related field required; advanced degree preferred.
Minimum of 8 years of experience in clinical research with proven management of complex global clinical trials.
Extensive experience leading high-volume and multi-site studies demonstrating operational and strategic oversight.
Strong understanding of GCP ICH and FDA regulatory requirements.
Proactive and independent vendor management experience including risk identification and mitigation.
Demonstrated ability to lead cross-functional teams and influence decision-making across multiple stakeholders.
Excellent verbal written and presentation communication skills with strong attention to detail.
Preferred Capabilities:
Experience in oncology or rare disease clinical programs preferred.
Proficiency with clinical trial management systems (CTMS) eTMF and EDC platforms.
Strong financial acumen with experience managing study budgets and contracts.
Ability to thrive in a fast-paced small-to-midsize biotech environment with a hands-on approach.
PMP certification or equivalent project management training preferred.
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $146000 - $201000. 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 Summary:The Senior Clinical Project Manager leads and manages complex clinical studies demonstrating advanced knowledge of clinical operations methodologies strong organizational and leadership capabilities and strategic insight. This role provides operational direction oversight and executiona...
Role Summary:
The Senior Clinical Project Manager leads and manages complex clinical studies demonstrating advanced knowledge of clinical operations methodologies strong organizational and leadership capabilities and strategic insight. This role provides operational direction oversight and executional excellence to ensure clinical trials are delivered on time within budget and in compliance with GCP ICH and FDA regulations. The Senior Clinical Project Manager works cross-functionally to align study objectives with program goals and contributes to process improvement initiatives within a fast-paced small-to-midsize biotech environment.
Key Responsibilities:
- Clinical Trial Leadership & Oversight (40%)
- Lead the planning execution and delivery of clinical trials within specified quality time and cost parameters. Oversee CFT performance ensure operational alignment with Clinical Operations program objectives and manage multiple studies concurrently.
- Cross-Functional Team Management (25%)
- Provide leadership and guidance to cross-functional study teams (CFTs) fostering collaboration accountability and problem-solving across functions. Mentor and delegate responsibilities to support staff as appropriate.
- Vendor & CRO Oversight (15%)
- Lead interactions and negotiations with CROs and vendors to ensure adherence to contractual obligations budget and study timelines. Proactively identify and mitigate operational risks to ensure high-quality deliverables.
- Process Optimization & Strategic Execution (10%)
- Evaluate current methodologies and identify opportunities for greater efficiency and effectiveness across clinical operations processes and systems.
- Stakeholder Communication & Engagement (10%)
- Communicate study progress challenges and outcomes to internal stakeholders maintaining transparency and alignment across program leadership and clinical operations management.
- Other duties and responsibilities as assigned.
Qualifications :
Required Qualifications:
Bachelors degree in health science or related field required; advanced degree preferred.
Minimum of 8 years of experience in clinical research with proven management of complex global clinical trials.
Extensive experience leading high-volume and multi-site studies demonstrating operational and strategic oversight.
Strong understanding of GCP ICH and FDA regulatory requirements.
Proactive and independent vendor management experience including risk identification and mitigation.
Demonstrated ability to lead cross-functional teams and influence decision-making across multiple stakeholders.
Excellent verbal written and presentation communication skills with strong attention to detail.
Preferred Capabilities:
Experience in oncology or rare disease clinical programs preferred.
Proficiency with clinical trial management systems (CTMS) eTMF and EDC platforms.
Strong financial acumen with experience managing study budgets and contracts.
Ability to thrive in a fast-paced small-to-midsize biotech environment with a hands-on approach.
PMP certification or equivalent project management training preferred.
Additional Information :
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $146000 - $201000. 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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