At Clinitude we are looking for a CDM Lead for our office in Cebu, the Philippines. The CDM Lead at Clinitude manages the end-to-end delivery of services related to data management for several projects. The CDM Lead will need ensure quality deliverables on time and within budget and to customer satisfaction. The CDM Lead provides leadership and vision to the team in the areas of project planning, execution and close out. The CDM Lead will need to comply with Good Clinical Practices (GCP), ISO14155, applicable regulatory guidelines, SOPs, policies and where applicable, CDM guidance documents.
We expect from a CDM Lead:
- To provide project management expertise to work with data manager team from sponsor, with internal team members to manage continuous process improvements, issue escalation, workload projections and provide technical expertise
- To provide and justify timelines, resources, processes to Clinitude Management team Belgium
- To ensure open communications, if applicable with data management team of client, and with Clinitude management team Belgium to manage and meet contractual obligations set with the client
- To meet with Clinitude team members on a regular basis to ensure milestones meet timelines and to ensure quality of data is delivered
- To ensure strong communications with functional leads, data management team, project managers and other stake holders
- To work with functional manager(s) to make sure resources are assigned
- To create and sign off on al data management documents (e.g. data management plan, data validation plan, ….)
- To implement a quality management plan
- To continuously look for opportunities to improve data management services and work together with the team to drive change across several projects
- To ensure timely resolutions for compliance issues
- To train and mentor junior clinical data associates
- To provide solution to the CDM department
- To coordinate and develop the clinical data management team Cebu
- Previous experience and proven competence in managing deliverables for projects through the DM life cycle
- Demonstrates expert data management skills
- Excellent understanding of database coding aspects and clinical data management methods
- Knowledge of medical terminology
- Knowledge of operating procedures
- Excellent communication, interpersonal and team work skills
- Project management skills
- Organizational and problem-solving skills
- Comprehensive understanding of drug development process and/or device development process
- Standard Microsoft Office knowledge
Minimum required education:
Bachelor degree, or equivalent in health, clinical, biological or computer sciences and a minimum of 4 years direct data management experience with 2 years as data management project lead.
What we offer
- Competitive compensation based on experience
- Traffic friendly office hours (2pm to 10pm) with a 2-hour flexible in.
- Flexible break times
- Convenient office location just across the street of Ayala mall, next to the Terminal and Mc Donalds, Jolibee etc.
- Medical insurance (dental included) and several allowances
- Above industry standard leave benefits
- Opportunity to grow into a lead position.
- Travel opportunities to Europe and get trainings in our Belgium office
- All the benefits of working in a lean and mean work environment
- You’re not a number but a true asset to the group.
- Less hierarchy and enormous learning opportunities of the business since you are not placed in a typical roll
- Make a big impact and get credited for it.
- Have a high influence in business decisions and boost your personal skillset.
- Possibility to develop your own personal ideas within the company
- Regular outings and dinner treats with the whole team
Please send your resume and motivation and get in touch with us by email at hr AT clinitude.com or call us at 032 415-5447