InnoCare Pharma
About the Company
InnoCare Pharma is a cutting-edge bio-pharmaceutical company dedicated to advancing healthcare through innovative therapeutic solutions. We specialize in the discovery and development of novel small molecules, antibodies, and ADC for the treatment of various diseases cover therapeutic areas including oncology and immunology.
http://www.innocarepharma.com
Job Summary The CPM / Sr. CPM will be responsible for the strategic planning, execution, and oversight of regional/global multi-centered oncology or autoimmune clinical studies. The role will focus on delivering high-quality clinical trials within the agreed timelines and budgets. You will lead cross-functional teams and external partners to ensure the smooth execution of clinical studies, from initiation to completion, while meeting regulatory, quality, and compliance standards.
About the Role The CPM / Sr. CPM will be responsible for the strategic planning, execution, and oversight of regional/global multiculturaled oncology or autoimmune clinical studies.
Responsibilities Timeline Management :
Develop and manage comprehensive project plans to ensure clinical trials are executed on time, within scope, and in line with corporate goals.
Track study progress and critical milestones, identifying risks and implementing mitigation strategies to keep projects on schedule.
Regularly report project status to leadership, ensuring transparency and clear communication across teams.
Collaborate with internal stakeholders, including medical, regulatory, and clinical operations teams, to ensure timely approvals and trial progression.
Quality Oversight :
Ensure all clinical activities comply with GCP, ICH guidelines, regulatory requirements, and company SOPs.
Oversee and manage CROs, vendors, and study sites to ensure high-quality data collection and adherence to protocol.
Lead cross-functional meetings to review study progress, identify issues, and implement corrective actions where necessary.
Perform quality reviews of essential study documents, such as protocols, informed consent forms, and study reports.
Financial Management :
Create and manage detailed study budgets, ensuring cost-effective execution of clinical trials.
Monitor actual trial costs against the budget, and proactively address variances to avoid financial overruns.
Negotiate contracts and manage the performance of CROs and other external vendors to ensure financial efficiency and quality delivery.
Provide financial forecasts and projections, working closely with finance and leadership teams to ensure proper resource allocation.
Cross-functional Collaboration :
Act as the main point of contact between clinical operations, medical affairs, regulatory affairs, and other stakeholders to drive project success.
Coordinate with data management, biostatistics, and safety teams to ensure the smooth integration of data and quality management.
Lead internal and external project team meetings, fostering a collaborative environment to solve issues and enhance performance.
Risk Management :
Identify project risks related to timelines, quality, and financials, and develop appropriate mitigation plans.
Actively manage issues and escalations, providing timely solutions to ensure the continuous progress of the trial.
Regulatory and Compliance :
Ensure all trials are conducted with high ethical standards and meet regulatory submission requirements for multiple regions (FDA, EMA, etc.).
Assist the regulatory affairs team in the preparation of regulatory filings, including INDs, CTAs, and other relevant submissions, by ensuring timely collection of required trial documents and data.
Qualifications
Educated to degree level (biological sciences, pharmacy or other health related discipline preferred) or relevant experience in a medical / nursing field
5+ years of experience in clinical trial management, with at least 3 years in a project management role
Demonstrated experience managing Phase I – III trials, preferably in autoimmune diseases or oncology
Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
Proven experience in managing timelines, budgets, and quality across multiple trials.
Strong leadership, communication, and problem-solving skills
Ability to manage multiple projects simultaneously, with strong organizational and multitasking abilities
Experience with clinical trial management systems (CTMS), electronic trial master files (eTMF), and other relevant software tools
Excellent interpersonal, verbal, and written communication skill (in English)
Excellent problem-solving capability through early identification; excellent computer literacy
Occasional travel may be required
Fluency in Mandarin is a plus
Flexibility with work hours; night and early morning TC with corporate office in China
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http://www.innocarepharma.com
Job Summary The CPM / Sr. CPM will be responsible for the strategic planning, execution, and oversight of regional/global multi-centered oncology or autoimmune clinical studies. The role will focus on delivering high-quality clinical trials within the agreed timelines and budgets. You will lead cross-functional teams and external partners to ensure the smooth execution of clinical studies, from initiation to completion, while meeting regulatory, quality, and compliance standards.
About the Role The CPM / Sr. CPM will be responsible for the strategic planning, execution, and oversight of regional/global multiculturaled oncology or autoimmune clinical studies.
Responsibilities Timeline Management :
Develop and manage comprehensive project plans to ensure clinical trials are executed on time, within scope, and in line with corporate goals.
Track study progress and critical milestones, identifying risks and implementing mitigation strategies to keep projects on schedule.
Regularly report project status to leadership, ensuring transparency and clear communication across teams.
Collaborate with internal stakeholders, including medical, regulatory, and clinical operations teams, to ensure timely approvals and trial progression.
Quality Oversight :
Ensure all clinical activities comply with GCP, ICH guidelines, regulatory requirements, and company SOPs.
Oversee and manage CROs, vendors, and study sites to ensure high-quality data collection and adherence to protocol.
Lead cross-functional meetings to review study progress, identify issues, and implement corrective actions where necessary.
Perform quality reviews of essential study documents, such as protocols, informed consent forms, and study reports.
Financial Management :
Create and manage detailed study budgets, ensuring cost-effective execution of clinical trials.
Monitor actual trial costs against the budget, and proactively address variances to avoid financial overruns.
Negotiate contracts and manage the performance of CROs and other external vendors to ensure financial efficiency and quality delivery.
Provide financial forecasts and projections, working closely with finance and leadership teams to ensure proper resource allocation.
Cross-functional Collaboration :
Act as the main point of contact between clinical operations, medical affairs, regulatory affairs, and other stakeholders to drive project success.
Coordinate with data management, biostatistics, and safety teams to ensure the smooth integration of data and quality management.
Lead internal and external project team meetings, fostering a collaborative environment to solve issues and enhance performance.
Risk Management :
Identify project risks related to timelines, quality, and financials, and develop appropriate mitigation plans.
Actively manage issues and escalations, providing timely solutions to ensure the continuous progress of the trial.
Regulatory and Compliance :
Ensure all trials are conducted with high ethical standards and meet regulatory submission requirements for multiple regions (FDA, EMA, etc.).
Assist the regulatory affairs team in the preparation of regulatory filings, including INDs, CTAs, and other relevant submissions, by ensuring timely collection of required trial documents and data.
Qualifications
Educated to degree level (biological sciences, pharmacy or other health related discipline preferred) or relevant experience in a medical / nursing field
5+ years of experience in clinical trial management, with at least 3 years in a project management role
Demonstrated experience managing Phase I – III trials, preferably in autoimmune diseases or oncology
Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
Proven experience in managing timelines, budgets, and quality across multiple trials.
Strong leadership, communication, and problem-solving skills
Ability to manage multiple projects simultaneously, with strong organizational and multitasking abilities
Experience with clinical trial management systems (CTMS), electronic trial master files (eTMF), and other relevant software tools
Excellent interpersonal, verbal, and written communication skill (in English)
Excellent problem-solving capability through early identification; excellent computer literacy
Occasional travel may be required
Fluency in Mandarin is a plus
Flexibility with work hours; night and early morning TC with corporate office in China
#J-18808-Ljbffr