(Senior) Project Manager, Belgium (Client-dedicated)

Submission for the position: (Senior) Project Manager, Belgium (Client-dedicated) - (Job Number: 173037)

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

PPD has an exciting opportunity for a (Senior) Project Manager (Clinical Study Manager), to join us onsite for one of our strategic partners in Belgium. PPD works in collaboration with this pharmaceutical partner; you will be dedicated to the client projects, processes, working within their teams and systems on behalf of PPD. You should ideally be based in Belgium (or nearby countries) and be open to travelling to their office 2-3 days per week in Ghent (ideally Tue-Thurs).

The PM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure.

Key responsibilities: Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan Leading CRO contracts negotiations together with our vendor manager Providing input into and/or developing study related materials such as Clinical Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms etc. Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays Ensuring that study Trial Master File is maintained and up to date Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of MedWatch reports to FDA, EMEA and other applicable regulatory authorities Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation Establishing and maintaining good relation with clinical site and study personnel Co-monitoring CROs personnel upon predefined plan Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to Project Manager or Senior Management, if needed Leading and guiding the internal clinical study team and chairing study team meetings Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan Ensuring that the assigned studies are executed according to our quality standards Responsible for risk management of the assigned studies: performing (pre-)study risk assessment and ensuring that mitigation steps for potential risks are taken Responsible and contact person during inspections/audits for the assigned studies together with the Quality Assurance representative The Sr PM will also participate in activities other than study-related which include but are not limited to: Providing input to the clinical development strategy/plan Co-writing/maintaining SOPs within the Clinical Operations department

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

PPD has an exciting opportunity for a (Senior) Project Manager (Clinical Study Manager), to join us onsite for one of our strategic partners in Belgium. PPD works in collaboration with this pharmaceutical partner; you will be dedicated to the client projects, processes, working within their teams and systems on behalf of PPD. You should ideally be based in Belgium (or nearby countries) and be open to travelling to their office 2-3 days per week in Ghent (ideally Tue-Thurs).

The PM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure.

Key responsibilities: Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan Leading CRO contracts negotiations together with our vendor manager Providing input into and/or developing study related materials such as Clinical Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms etc. Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays Ensuring that study Trial Master File is maintained and up to date Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of MedWatch reports to FDA, EMEA and other applicable regulatory authorities Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation Establishing and maintaining good relation with clinical site and study personnel Co-monitoring CROs personnel upon predefined plan Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to Project Manager or Senior Management, if needed Leading and guiding the internal clinical study team and chairing study team meetings Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan Ensuring that the assigned studies are executed according to our quality standards Responsible for risk management of the assigned studies: performing (pre-)study risk assessment and ensuring that mitigation steps for potential risks are taken Responsible and contact person during inspections/audits for the assigned studies together with the Quality Assurance representative The Sr PM will also participate in activities other than study-related which include but are not limited to: Providing input to the clinical development strategy/plan Co-writing/maintaining SOPs within the Clinical Operations department

Education and Experience:

Bachelor's degree or licensed certified health care training or equivalent combination of education and experience Previous biopharma/biotech experience preferred in a Study Management role Has proven understanding and experience of working within clinical development (equivalent to 4-5 years) - experience with AMLExperience with APAC Can demonstrate evidence of a period of successfully managing and/or leading individuals/team Experience using project management software Solid understanding of how to craft and manage a project budget Must possess a valid passport, (travel approx 10%)

Knowledge, Skills and Abilities: Knowledge of the key principles of cross functional project management (Time, Quality, Cost) Solid financial acumen Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen Displays effective communication skills (listening, oral, written) and can communicate in English and French language (oral,written) Sound interpersonal skills, is flexible and adapts to changing situations Has the ability to persuade, convince, and influence or impress others Is organized, proficient at multi-tasking with good attention to detail Able to lead, motivate and coordinate teams. Coach/mentor team members as appropriate Able to delegate, effectively prioritizes own and workload of project team members Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc Possesses cross cultural awareness and is able to adapt appropriately Has an understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology Has experience with leading, liaising and coordinating cross-functional project teams Has knowledge/understanding of clinical development guidelines and Directives

If you are interested in learning more, please send upload your CV online. Only short-listed candidates will be contacted.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD - *LI-MP1

Education and Experience:

Bachelor's degree or licensed certified health care training or equivalent combination of education and experience Previous biopharma/biotech experience preferred in a Study Management role Has proven understanding and experience of working within clinical development (equivalent to 4-5 years) - experience with AMLExperience with APAC Can demonstrate evidence of a period of successfully managing and/or leading individuals/team Experience using project management software Solid understanding of how to craft and manage a project budget Must possess a valid passport, (travel approx 10%)

Knowledge, Skills and Abilities: Knowledge of the key principles of cross functional project management (Time, Quality, Cost) Solid financial acumen Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen Displays effective communication skills (listening, oral, written) and can communicate in English and French language (oral,written) Sound interpersonal skills, is flexible and adapts to changing situations Has the ability to persuade, convince, and influence or impress others Is organized, proficient at multi-tasking with good attention to detail Able to lead, motivate and coordinate teams. Coach/mentor team members as appropriate Able to delegate, effectively prioritizes own and workload of project team members Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc Possesses cross cultural awareness and is able to adapt appropriately Has an understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology Has experience with leading, liaising and coordinating cross-functional project teams Has knowledge/understanding of clinical development guidelines and Directives

If you are interested in learning more, please send upload your CV online. Only short-listed candidates will be contacted.

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD - *LI-MP1

Submission for the position: (Senior) Project Manager, Belgium (Client-dedicated) - (Job Number: 173037)