The Clinical Operations Manager role is pivotal for the Medical Affairs department. The Department runs Moleac’s international drug development programs with two focus areas: extension of indications for our main marketed product and conduct of clinical studies aiming at the regulatory approval of our new products in major markets. Our products address the needs of patients’ recovery from a loss of brain functions after a brain injury (Stroke, Traumatic Brain Injury) as well as addressing the need of patients with cognitive deficits. You will be reporting to the head of Medical Affairs and you will have abundant opportunity to work with an international team of highly diverse background and deep expertise.
Major Accountabilities:
• Project Delivery: Accountability for delivering clinical trials on time, within budget, and meeting quality standards.
• Regulatory Compliance: Ensure compliance with all applicable regulations and guidelines; manage audits and inspections effectively.
• Team Performance: Responsibility for leading and developing a high-performing clinical operations team.
• Budget Oversight: Accountability for managing the clinical trial budget and ensuring financial efficiency.
• Data Integrity: Maintain the highest standards of data quality, integrity, and compliance throughout the trial.
• Stakeholder Engagement: Foster and maintain strong relationships with internal and external stakeholders, ensuring effective communication and collaboration.
Key Responsibilities and Activities:
1. Study Planning and Execution:
o Develop and implement study protocols in collaboration with Moleac Medical Advisor.
o Develop study planning in accordance with key study milestones, ressources and budget, and ensure its timely execution
o Ensure appropriate support to the investigational study sites and motivation of site study teams to meet clinical trial recruitment targets
o Oversee the initiation, execution, and close-out of clinical trials, ensuring adherence to company’s clinical development strategy
o Anticipate, identify and resolve issues that may impact quality and/or timely completion of clinical studies
2. Site Management and Relations:
o In full cooperation with study Medical Advisor, dentify, evaluate, and select investigational sites; establish relationships with Principal Investigators (PIs) and site staff.
o Monitor site performance and address any issues that may arise during the trial.
o Develop contingency plans as needed, prepare and activate action plans to ensure patient recruitment in the clinical study is progressing without delay
3. Vendor Management:
o Develop project work packages specifications, organize bidding process, ensure vendor qualifications and track record, select vendors
o Lead cross-functional teams, including team members from Moleac, CROs and other vendors (Clinical Research Associates (CRAs), data managers, site staff, IT and other system’s support, etc..).
o Provide mentorship to junior staff and team members; foster a collaborative team environment.
4. Regulatory Compliance:
o Ensure that all clinical trials comply with local and international regulations, including ICH-GCP guidelines.
o Contribute to development and updates of Moleac clinical research SOPs
o Maintain up-to-date knowledge of regulations and procedures to ensure compliance across all study phases.
5. Data Oversight and Quality Control:
o Ensure the integrity, quality, and accuracy of clinical trial data.
o Conduct regular data reviews and queries to facilitate timely resolution of data discrepancies.
o Prepare and organize for any study and/or sponsor audit/inspection, either conducted by a regulatory authority, an IRB, or commissioned by Moleac
6. Budget Management:
o Develop and manage study budgets, including forecasting and tracking expenses.
o Work closely with finance to ensure timely payments to sites and vendors.
7. Clinical Trial Reporting:
o Prepare and present regular progress reports to senior management and project stakeholders.
o Compile and submit necessary documents for regulatory approvals and updates.
8. Risk Management:
o Identify potential risks and challenges in clinical trial operations and develop mitigation strategies.
o Implement corrective actions as needed to address operational issues.
9. Stakeholder Communication:
o Serve as the primary point of contact for operational study-related matters and communications among internal teams, sponsors, and regulatory authorities.
o Facilitate regular meetings to keep all stakeholders informed on study progress and any issues.
Requirements
a. Bachelor of Science or Master’s Degree in nursing, life science, or related field
b. Minimum 5 years of clinical research experience, of which 2 years as Project Manager, for clinical studies in CRO and/or pharmaceutical/biotech organization
c. Proven track record showing clear proficiency in clinical project management skills including use of appropriate software.
d. Experience in negotiating with vendors/site contractors and managing study budget
e. Thorough understanding of FDA, ICH and GCP guidelines
f. Proven complex problem-solving skills
g. Solid vendor management skills, e.g., CRO, laboratory & clinical supply logistics
h. Broad understanding of clinical operations related to clinical development functions
i. Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
j. Ability to effectively interface with medical personal at clinical site(s)
k. Ability to lead multi-disciplinary and cross-functional teams
l. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
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