Clinical Study Manager

Are you energized by the opportunity to partner with key leaders in global medical science to enhance global operational support?  If so, this Clinical Study Manager could be an exciting opportunity to explore.

A Clinical Study Manager provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of countries: across all therapy areas to the required quality standards, GSK written standards, local regulations and ICH GCP. Additionally, you will provide operational support to the Global Medical Sciences team within the business and provide flexible operational support within various functions across Global Medical Sciences.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Leads the local study team consisting of within-country clinical operations team members, cross functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery, providing both matrix leadership and project management of study activities within the country/countries.

• Serves as the operational point-of-contact between the central GSK study team and within-country study team. The LDL collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies).

• Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH guidelines, GSK Corporate, Vaccines, and local SOPs and POLs.

• Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery.

• Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.

• Identifies and resolves or escalate risks and issues that may impact study delivery.

• Provides feedback on performance, capabilities and competencies of study members to line management. As required, reviews and approves monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.

• Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.

• As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.

• As required, prepares the local Informed Consent Form and coordinates the submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study.

• Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of disease area being studied, competitive landscape within country/countries, local treatment/immunization guidelines and local health care system requirements.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree

• 5 or more years of industry project management experience

• Experience providing operational support across global scientific and medical functions.

• Experience with phase I-IV of the clinical trial

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Advanced Degree in Life Sciences

• Strong stakeholder management experience

• Proven ability to influence and build consensus

#LI-GSK

The annual base salary for new hires in this position ranges from $112,500 to $187,500 taking into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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