Abbott Senior Clinical Trial Manager in Singapore, Singapore

MAIN PURPOSE OF ROLE:

Accountable for the operational conduct of clinical trials with the CRO Project Manager (PM) and manage within the Clinical Team the collaboration of the Clinical Research Organization (CRO) with the various Abbott specialists to ensure the completion of study objectives in accordance with the applicable regulations.

MAIN RESPONSIBILITIES:

Manage operational study start-up activities and provide operational expertise in order to ensure optimal collaboration of various Abbott specialists with the CRO team and its Project Manager and timely subject recruitment:

  • plan, coordinate and oversee all start-up activities of internal disciplines (Drug supply, Regulatory, Safety, Data Management etc.) and being the main contact (supervise, steer etc.) for involved CROs and other external vendors, if applicable

  • agree and/or ensure implementation of study principles and deliverables (safety, timelines, quality, milestones, budget, etc.) and follow-up to guarantee adherence

  • facilitate communication and ensure adequate collaboration between all involved parties

  • communicate effectively processes to in-/external service groups and clients in accordance with all applicable procedures (e.g. BIOM, Task List etc.)

  • participate in teams related to trial conduct (e.g. Clinical Study team, Extended Joint Abbott-CRO Clinical Team, Drug supply team etc.) and organize/attend external key study meetings (Kick-off meeting, CRA meeting, Investigator meeting, etc) as applicable

  • read, review and/or assist in preparation of core project documents (e.g. Investigator Brochure, Concise Clinical Development Plan, Protocol, Informed Consent Form) as applicable

  • review key Clinical Trial Management strategies like: Communication plan / Feasibility / Patient & Site recruitment / Drug supply / EC&RA Submission, etc.

Oversee and manage with the CRO Project Manager the study conduct in order to ensure adequate and timely delivery of study data and documentation in Trial Master File (TMF):

  • use efficiently tools to monitor status of e.g. patient recruitment and take corrective action if necessary

  • ensure respect of agreed deliverables, and communicate efficiently within the teams (timelines, milestones, budget, quality)

  • co-coordinate timely availability of all supplies important for the conduction of trials, including the re-supply of sites

  • monitor data collection, cleaning and data transfer with respect to completeness, quality and timely delivery of the final results

  • review audit reports and ensure issues are resolved

  • participate in strategic decision making to improve recruitment

  • apply operational risk management plan (if applicable)

  • support activities to generate study report / dossier

  • supervise and monitor the transfer and archiving of the clinical file (e.g. TMF)

Supports the development, maintenance and application of an Operational Clinical Trial Risk Management Plan (ORMP), as designed by the PM (CRO) in order to minimize or prevent any obstacles to study deliverables:

  • identify and prioritize potential risks for the different deliverables at early stage of study start-up, involving all parties (CRO, etc), with the contracted CRO

  • generate and communicate a risk management plan, or review such created by CRO

  • review ORMP in adequate intervals and revise, if needed

  • apply agreed risk management strategies, if necessary (e.g. visit study sites and/or study countries to stimulate patient recruitment etc.) in conjunction with CRO

  • ensure proactive conduct of the study to avoid or minimize risks according to the regularly updated ORMP (in conjunction with the CRO)

  • alert all relevant parties of spontaneously occurring blocking issues, affecting timelines/milestones etc. and follow-up until resolution

Acquire, maintain and share knowledge and expertise related to Clinical Trial Management as well as to project specific medical and scientific aspects in order to ensure adequate implementation of operational, medical and strategic aspects and needs of projects, and to conduct studies, respecting laws and regulations:

  • fulfill diligently the requirements of training needs (e.g. GCP/ICH, SOP/GOP)

  • attend operational and – if applicable – medical / scientific conferences, symposia and expert courses

  • attend and/or present at CTM and Global Clinical Operations meetings (OSMB, GCDMT as applicable)

Contribute to and/or advise on update of processes, guidelines and procedures, relevant for Clinical Trial Management in order to maximize efficiency and success of clinical trials and submissions:

  • contribute to SOPs & GOPs update / training and review / implement in time

  • review and give input on templates like protocol, Informed Consent Form (ICF), and guidance like Task list, BIOM etc

  • communicate study related issues and Lessons Learned effectively within the CTM group (CTM meeting, Action list)

  • communicate effectively processes to in-/external clients in accordance to BIOM, Task List and other approved guidelines and SOPs/GOPs (e.g. by generating specs)

QUALIFICATIONS:

Education:

  • Academic or higher non-academic with medical or scientific/pharmaceutical background

Experience/Background:

  • Minimum 4-5 years of experience in Clinical Trial Management as CTM / PM, across different Clinical development phases

  • Large experiences in Clinical Trial Management, recognized leader and strong core competencies without significant deficiencies

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com