Description
The Senior Clinical Operations Manager (Sr. COM) is responsible for the day-to-day management of an assigned team of both permanent and contracted staff (e.g., Clinical Research Associates (CRA)/(cCRA)), Clinical Operations Support personnel, and other team members with direct reports etc.) overseeing their performance and training, ensuring adequate monitoring and support, hiring and allocating resources to projects, identifying quality issues related to Clinical activities and establishing action plans to address them. The Sr. COM also participates in process improvement initiatives to improve the quality and efficiency of monitoring services and serves as a mentor and trainer for new and/or more junior COMs
This role will be perfect for you if:
- Focusing on dermatology and developing an expertise in this therapeutic area is interesting to you
- You enjoy working for a mid-sized CRO where your contributions are noticed and valued
- You enjoy managing the day to day of CRAs and contractual CRAs
RESPONSIBILITIES
More specifically, the Senior Clinical Operations Manager must:
- Ensure that clinical monitoring activities of their assigned team are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget, and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.
- Oversee the performance of their direct and indirect reports, ensuring they are meeting performance objectives and taking appropriate remedial actions as required.
- Implements professional development and performance evaluations.
- Supports the creation and delivery of training of Clinical Operations personnel, including the training and mentoring of more junior COMs.
- Ensures team members’ consistent use of study tools and training materials.
- Collaborate in the creation of new key performance indicators (KPIs) and performance goals for Clinical Operations personnel.
- Tracks Clinical Operations metrics (e.g., such number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, time sheets, expense reports and required trainings.)
- Performs Quality Assessment Visits - (QAV) with CRAs.
- Identifies quality issues related to Clinical Operations activities through QC checks, project meetings, site and team communications, site visit reports and follow-up letters, eTMF completeness, QAVs, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions.
- Serves as a point of contact for Clinical Operations personnel and other team members for assigned projects or initiatives. Evaluate hiring needs including the proportion of employees to contractors as well as level of experience (e.g. CRA 2 vs Sr CRA) to maintain profitability.
- Interview potential Clinical Operations candidates, including making recommendations for hiring.
- Assist in the evaluation, testing, and implementation of new system.
- Serve as a Subject Matter Expert (SME)/ support resource for clinical systems.
- Serve as a management contact for sites, project teams, and sponsors when issues related to Clinical Operations and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.
- Assist with continuous review of current processes, and implementation of agreed process improvements or develop new processes to enhance efficiencies.
- Liaise with project teams to identify strategies to accelerate the delivery and efficiency of project milestones.
- Allocate and track personnel to projects, strategizing to balance the ratio of employees vs contractors and hours billed to projects to maintain profitability.
- May conduct on-site or remote monitoring visits to offer support to project teams.
- May perform site visit report review and track site visit report metrics to ensure compliance.
- Provide input to Clinical Operations Plans, Tools, and. SOPs with a focus to improve efficiencies and quality.
- Provide input on the preparation of requests for proposals (RFPs) and requests for information (RFIs) for new studies including preparation of clinical monitoring risk-based monitoring budgets. May participate in proposal defense meetings and internal study kick-off meetings.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
Education
- Bachelor’s Degree in a field relevant to clinical research.
Experience
- Minimum of 10 years of experience in clinical research in the biotechnology, pharmaceutical, or CRO industry, with at least 5 years of relevant experience as a Sr. CRA, or at least 2 years as a Project Manager, Clinical Trial Manager, or equivalent job role
- Good experience in the field of monitoring.
- Experience in a CRO is an asset.
Knowledge and skills
- Excellent oral and written English skills.
- Excellent mastery of Microsoft Office suite (Word, Excel, Power Point).
- Ability to work in a fast-paced evolving environment and establish good relationships with colleagues and sponsors.
- Ability to liaise successfully with clinical project teams and other departments.
- Quick learner, good adaptability and versatile.
- Excellent leadership, judgement, and problem-solving skills.
- Strong organizational, communication, time management and multi-tasking skills.
- Travel up to 20% of the time.
- Good knowledge of good clinical practices, applicable Health Canada, Food and Drug Administration (FDA), European Medicines Agency (EMA) regulations/guidelines and other applicable regulatory requirements.
Our company
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
- Permanent full-time position
- Vacation, PPK, health allowance
- Home-based position with teleworking allowance
- Ongoing learning and development
Work location
This position is opened to candidates across Poland (home-based position).
Recruitment process: what to expect
- As part of the recruitment process for this position you will meet various team members at Indero
- The first interview will be conducted by Teams (30 minutes) and the second via video conference (1 hour)
- The second interview includes a short presentation for which reasonable advance preparation is required (preparation is not timed and can be completed over a few days). You may think of it as one interview question for which you have the opportunity to develop a strong structured response that goes beyond the surface.
About Indero
Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Poland.
