The CTM Functional Manager will provide operational leadership to a team of Clinical Trial Managers within GCDO, driving the study placement and country/site management activities within an assigned Therapeutic Area. He/she is responsible to ensure all trials are timely and appropriately staffed for the assigned TA, and oversees that studies are carried out within agreed timelines and in line with all the applicable SOPs and regulatory requirements.
This position is responsible for the functional management of a team of Clinical Trial Managers, overseeing staff development, project assignments, workload distribution, and issue resolution with direct reports. He/she ensures alignment of goals with organizational objectives and assigned trial objectives as defined in the GC(D)O local goals and objectives.
The CTM Functional Manager may act as the business owner for assigned processes and/or support continuous process improvements. This position influences Clinical Trial Management decisions as appropriate and understands and aligns with long-term business needs.
This position makes decisions and recommendations that will have a direct impact on resource allocation and the success of the trial delivery.
1. Provide operational leadership over a team of CTMs and the projects they manage:
1. Lead the CTM team so that execution of clinical trials is done according to required timelines and according to protocol, International Guidelines for Good Clinical Practice, international and national SOPs and local procedures and regulations.
2. Ensure a strong connection to the country teams is built in every trial, and that local as well as global perspectives are incorporated in the trial setup.
Oversee resource allocation for assigned TA portfolio. Establish and manage resource allocation within team, oversee workload of the staff to ensure optimal utilization of resources.
Set operational objectives for his/her team and ensures alignment with company, project team, departmental objectives.
Develop strong working relationships with key business partners, and create a culture of cross-functional collaboration across all teams
1. Works effectively with GCO Regional/country Heads and business support groups as well as Portfolio Delivery Operations, Quality Management, IDAR, Regulatory, Clinical Supply Chain and Q&C.
2. Align with the respective GCDO Operations Head and GCDO Program Leaders.
Build a high performing team through on-going development, performance management and coaching. Take ownership for ensuring a strong pipeline of leaders within the organization through the Succession Planning process, and foster employee engagement, inclusion and Credo Behaviors.
Lead/support improvement opportunities across clinical operations, and provide leadership for the development and implementation of innovative business practices and improved business processes.
Lead the effective and timely resolution of issues escalated by the countries or site facing vendors. Provide clear feedback on performance of vendors interfacing with CTMs and propose mitigations. Strong interaction with the PDO, GCO, Central Support Groups, IDAR, Clinical Supplies Unit (CSU), Q&C and external vendor groups.
This position reports into the Head of Clinical Trial Management
Contacts inside the company:
GCDO Operational Leader, GCDO Trial Leader, GCDO Program Leader, Functional Management, other CTM FMs, R&D Country Managers/Directors, Regional Therapeutic Area Experts, Global Operations Support, IDAR, Central Monitoring Managers, Clinical Supply Chain, Quality Management & Training group, Quality Assurance group, Clinical Trial Regulatory Liaisons.
Contacts outside the company: Vendors as applicable, site study staff as needed
EDUCATION AND EXPERIENCE REQUIREMENTS:
BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy),
Minimum of 8 years clinical trial management experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
Requires clinical research operational knowledge, project planning/management and communication skills. Should be flexible and have experience and ability in managing global or regional teams in a virtual environment.
Demonstrated experience managing and mentoring clinical operations team members. Effective leadership skills and proven ability to foster team productivity and cohesiveness is required.
Experience with CRO and vendor management and oversight is preferred.
Specific therapeutic area experience may be required depending on the position.
Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
Computer literacy is also required.
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Netherlands-North Brabant-Breda
Janssen Pharmaceutica N.V. (7555)
Clinical Trial Coordination